Investigational projects.

Ongoing Clinical Trials.

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Clinical trials in PARKINSON

Lundbeck: LU18252A:
Interventional, open-label, exploratory study, investigating the safety, tolerability, pharmacokinetics, and efficacy of Lu AF28996 in patients with Parkinson’s disease.

BioArctic: BAN0805-201 (EXIST):
A Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of exidavnemab in patients with mild to moderate Parkinson’s disease receiving stable medication for symptomatic Parkinson’s disease.
BIOGEN: 283PD201 (LUMA)
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson’s Disease

Clinical trials in ALZHEIMER

Bristol-Myers Squibb: CN008-003 (TARGET TAU-1):
A Randomized, Double-blind, Placebo-controlled, Global Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Participants with Early Alzheimer’s Disease (TargetTau-1).

Acumen: ACU193-201 (ALTITUDE-AD):
A Phase 2/3 Double-Blind, Randomized, Placebo-Controlled Adaptive Design Trial to Evaluate the Efficacy and Safety of Intravenous ACU193 in Early Alzheimer’s Disease.

Nesté Health Sciences: 2302-CLI (COGNIKET-MCI):
A prospective, randomized, double-blind, placebo-controlled, multi-center, multi-country, pivotal trial to study the effects of a nutritional intervention of ketogenic medium-chain triglycerides (kMCT) and B-vitamins on cognitive functioning in older adults with Mild Cognitive Impairment.
ROCHE: BP42155 (BrainShuttle AD)
A randomized, double-blind, placebo-controlled, multiple ascending dose, parallel group study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7126209 after intravenous infusion in patients with prodromal or mild to moderate Alzheimer’s disease.

Other ongoing studies

Parkinson's disease


-ROCHE: BN42358 (PADOVA)
Multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous prasinezumab in participants with early Parkinson’s disease.

-NEURODERM: ND0612-007 (BouNDless)
A multicenter, randomized, active-controlled, double-blind, double-masked, parallel-group clinical study to investigate the efficacy, safety, and tolerability of a continuous subcutaneous infusion of ND0612, compared with IR-LD/CD (immediate/controlled-release levodopa/carbidopa) in patients with Parkinson’s disease who experience motor fluctuations.

-CEREVEL: CVL-751-PD-004 (Tempo-4)
A 58-week open-label trial of Tavapadon in Parkinson’s disease.

-ROCHE: BP39529 (PASADENA)
A 52-week, randomized, double-blind, placebo-controlled, Phase 2 study to evaluate the efficacy of intravenous RO7046015 (PRX002) in participants with early Parkinson’s disease with a 52-week blind extension.

Alzheimer’s disease

-Roche: BP 44745 (GABRIELLA):
A Phase II, Randomized, Double-blind, Placebo controlled, Multiple dose, Multicenter parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7269162 following Daily oral administration in Participants at Risk for or at the Prodromal stage of Alzheimer’s disease.

-PROTHENA: PRX012-102 (ASCENT-2)
Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of PRX012 in Subjects with Alzheimer’s Disease.

-ABBVIE: M23-515 (ABRO-AD)
A Phase 2b Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ABBV-552 in Participants with Mild Alzheimer’s Disease.

-NOVO NORDISK: NN6535-4730 (EVOKE)
A phase 3, randomized, double-blind, placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer’s disease.

-NOVO NORDISK: NN6535-4725 (EVOKE Plus)
A randomized, double-blind, placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer’s disease.

-UCB: AH003 (TOGETHER). Double-blind, patient and investigator, placebo-comparative study to assess the efficacy, safety, and tolerability of bepranemab (UCB0107) in patients with prodromal to mild Alzheimer’s disease (AD), followed by an open-label run-in. Phase II.

-JANSSEN: 63733657ALZ2002 (AuTonomy)
A phase 2, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of JNJ-63733657, an anti-Tau monoclonal antibody, in patients with early Alzheimer’s disease.

-EISAI: BAN2401-G000-301 (CLARITY)
An 18-month, double-blind, parallel-group, placebo-controlled study with an open-label extension phase to confirm the safety and efficacy of BAN2401 in subjects with early Alzheimer’s disease.

Udic

Other studies

-IMMUNOVANT: IMVT-1401-301 (FLEX)
A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG). IP: Dr Josep Gámez.

-Noema: NOE-TTS-201 (ALLEVIA-2):
A Double-blind, Placebo-controlled, Phase II/III, Multi-center, Twelve-week Prospective Study to Evaluate the Efficacy and Safety of Gemlapodect in Adult and Adolescent Patients with Tourette Syndrome.

-ABLIVA: KL1333-2020-104A (FALCON). Adaptive, randomized, double-masked, parallel-group, double-masked, flexible-dose, flexible-dose, placebo-comparative intervention study to evaluate the efficacy of KL 1333 in adult patients with primary mitochondrial disease (PMD). Phase 3. IP: Dr. Josep Gámez.

-IMMUNOVANT: IMVT-1401-2401: A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants with Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). 2023. PI Dr. Josep Gámez. Hospital Universitari General de Catalunya. Fase 2b.

Uncoming projects...

-ROCHE: Trontinemab phase 3. WN 45443. A phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group efficacy and safety study of Trontinemab in patients with early Alzheimer’s disease (MCI to mild Dementia due to AD).

-DENALI: DNLI-C-0009. A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson’s Disease (LRRK2-PD).

-Janssen: 64042056ALZ2001 (RETAIN):
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study, to Assess Efficacy, Safety and Immunogenicity of JNJ-64042056, a Phosphorylated Tau Targeted Active Immunotherapy, in Participants with Preclinical Alzheimer’s Disease.

Clinical trial history

Parkinson's disease

CVL-751-PD-001 (TempPo-1)
A 27-week, double-blind, randomized, placebo-controlled, parallel-group, phase 3 trial of the efficacy, safety, and tolerability of two fixed-dose tavapadon in early Parkinson’s disease.

ANNOVIS: ANVS-22001
A 6-month prospective, randomized, double-blind, placebo-controlled clinical trial investigating the efficacy, safety, and tolerability of two different doses of buntanetap or placebo in patients with early Parkinson’s disease.

SUN PHARMA: SPARC CRL18-06 (PROSEEK)
A phase 2, randomized, double-blind, placebo-controlled study of K0706 in patients with early Parkinson’s disease to evaluate the safety and efficacy of tyrosine kinase inhibition of Abl.

CVL-751-PD-001 (TempPo-3)
A Phase 3, double-blind, randomized, placebo-controlled, parallel-group, flexible-dose, 27-week trial to evaluate the efficacy, safety, and tolerability of tavapadon as add-on therapy for Parkinson’s disease in adults with motor fluctuations treated with levodopa.

BIOGEN: 254PD101 (REASON)
A Phase 1 Single, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults with Parkinson’s Disease.

CONTERA: JM010-CS03 (ASTORIA)
Randomized, double-blind, placebo-controlled, parallel-group study in Parkinson’s disease patients with moderate to severe dyskinesia to evaluate the efficacy, safety, and tolerability of two dose combinations of JM-010.

– BIOGEN: 283PD302 (LIGHTHOUSE)
A phase 3, multicenter, randomized, double-blind, placebo controlled study to determine the efficacy and safety of biib122/dnl151 in participants with parkinson’s disease  and pathogenic lrrk2 variants

– CTH-301. An open label extension study with sublingual apomorphine to assess its long-term safety (for 3 years) in fluctuating Parkinsonian patients.

– PHARMA TWO 2: P2B001-003. A Phase 3, twelve-week, multicenter, multinational, randomized, double-blind, double-dummy, parallel-group study to determine the efficacy, safety, and tolerability of once-daily P2B001 compared to its individual components in subjects with Parkinson’s disease.

– IMPAX: IPX203-B16-03. An open-label extension to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson’s disease patients with motor fluctuations.

– IMPAX: IPX203-B16-02 (RISE-PD). Randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in patients with Parkinson’s disease and motor fluctuations.

– SUNOVION: CTH-302. An open-label, randomized, crossover trial using a single-blind rater to evaluate APL-130277 compared with subcutaneous Apomorphine in levodopa-responsive subjects in complicated Parkinson’s disease with motor fluctuations.

– BIOGEN: 228PD201 (SPARK). A Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of BIIB037 in subjects with early symptomatic Alzheimer’s disease.

– PREXTON: PXT-CL17-001 ( AMBLED). A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Arm Phase IIa Trial to Evaluate the Efficacy, Safety, and Tolerability of 28-Day Oral Treatment with PXT002331 to Reduce Motor Complications of Levodopa Treatment in Patients with Parkinson’s Disease experiencing end-dose fading and levodopa-induced dyskinesia.

– INTEC PHARMA: IN11004 and IN11004E. A phase III, multicenter, randomized, double-blind, double-dummy, active-controlled study to compare the efficacy and safety of the gastric retention tablet and controlled release (accordion pills) carbidopa/ levodopa (AP-CD/LD) and immediate-release CD/LD in patients with fluctuating Parkinson’s disease.

– BIOTIE/ACORDA: TOZ CL-05. A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Extension Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End-of-Dose “Wearing -Off.

– CIVITAS/ACORDA: CVT-301-004 (SPAN-PD). A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena).

– CIVITAS/ACORDA: CVT 301-005. Randomized study to investigate the safety and effect of CVT301 (inhaled Levodopa) compared to standard treatment for Parkinson’s disease with motor fluctuations (off).

– OSMOTICA: OS320-3006 (ALLAYD-II). Multicenter, randomized, placebo-controlled, double-blind trial to evaluate the efficacy and safety of “extended release” amantadine for 26 weeks in Parkinson’s disease with levodopa-induced dyskinesias.

– OSMOTIC: OS320-3005 (ALLAYD-I). Multicenter, randomized, placebo-controlled, double-blind trial to evaluate the efficacy and safety of “extended release” amantadine for 16 weeks in Parkinson’s disease with levodopa-induced dyskinesias.

– BIAL: BIA 91067-301. A Phase III Study to evaluate Efficacy and Safety of BIA 91067-301 in patients with Idiopathic Parkinson’s disease with Wearing Off phenomenon treated with Levodopa and a Dopa decarboxylase inhibitor (IDDC) by means a multicenter clinical trial, double-blind, randomized active and placebo controlled, parallel group trial.

– MUNDIPHARMA: OXN 2504. Phase III, multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and tolerability of OXN PR for the treatment of severe pain associated with Parkinson’s disease.

– NOVARTIS: CAFQ056 A2299. Phase II/III study of open treatment to evaluate the safety, tolerability and efficacy of AFQ056 in levodopa-induced dyskinesias in patients with Parkinson’s disease.

– NOVARTIS: CAFQ056 A2223. Phase II double-blind, placebo-controlled, fixed-dose, multicenter, 13-week follow-up study to evaluate the efficacy and safety of modified-release AFQ056 in reducing moderate to severe levodopa-induced dyskinesias in patients with Parkinson’s disease.

– NOVARTIS: CAFQ056 A2222. Phase II, double-blind, placebo-controlled, fixed-dose, multicenter, 12-week follow-up study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe levodopa-induced dyskinesias in patients with Parkinson’s disease.

– MERCK SCHERING PLOUGH: P05664. Phase 3, double-blind, placebo- and active-controlled, range-finding, efficacy and safety study of Preladenant in subjects with early Parkinson’s disease. PI: Dr. E. Balaguer, at General Hospital of Catalonia & PI: Dr. A. Ugarte, at Sant Joan de Déu Hospital, Manresa.

– MERCK SCHERING PLOUGH: P06153. Phase III active-controlled, double-blind, double-dummy extension study of Preladenant in subjects with moderate to severe Parkinson’s disease.

– MERCK SCHERING PLOUGH: P04938. A 12-week, double-blind, placebo- and active-controlled phase 3 efficacy and safety study of Preladenant in subjects with moderate to severe Parkinson’s disease.

– SCHWARZ BIOSCIENCES / UCB: SP1066. A multicenter, phase I, randomized, double-blind, two-way cross-over study to compare the adhesiveness of two different Rotigotine patch formulations in subjects with Parkinson’s disease.

– MERCK SERONO: OLE28850. Open-label Phase III study to determine the long-term safety of safinamide in patients with Parkinson’s disease.

– MERCK SERONO: EMR 701165-024. Phase II, double-blind, randomized, placebo-controlled, parallel-group study to explore the possible beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment.

– IMPAX Pharmaceuticals: IPX066-B09-03. Study to evaluate the safety and efficacy of IPX066 in advanced Parkinson’s disease. An open label extension.

– IMPAX Pharmaceuticals: IPX066-B09-02. A phase III study to evaluate the safety and efficacy of IPX066 in advanced Parkinson’s disease.

– NOVARTIS: CAFQ056A2208. Multicenter, double-blind, placebo-controlled, fixed-dose, 13-week study to evaluate the efficacy and safety of AFQQ056 in reducing moderate and severe levodopa-induced dyskinesias in patients with Parkinson’s disease.

– ACADIA: ACP-103-014. A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease.

– BOEHRINGER-INGELHEIM: BI 248.634. Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson’s disease (PD).

– BOEHRINGER-INGELHEIM: BI 248,525. Randomized, double-blind, double-blind, placebo-controlled, 3-parallel-group study to compare the efficacy, safety, and tolerability of Pramipexole ER versus placebo and Pramipexole IR, administered orally during a 26-week maintenance phase in patients with advanced Parkinson’s disease treated with levodopa.

– SCHWARZ PHARMA: SP 873. International, “proof of concept” clinical trial to assess the efficacy and safety of Rotigotine, administered intranasally in advanced Parkinson’s disease with motor fluctuations and dyskinesias.

– SCHWARZ PHARMA: SP 833. Multicenter, open-label extension clinical trial to assess the efficacy, tolerance and safety of Rotigotine, administered in subcutaneous patches, in patients with initial Parkinson’s disease and sleep disorders.

– SCHWARZ PHARMA: SP 825. Ropinirole-controlled, randomized, multicenter clinical trial to evaluate the efficacy, tolerance and safety of Rotigotine, administered in subcutaneous patches, in patients with initial Parkinson’s disease and sleep disorders.

– SCHWARZ PHARMA: SP 516. Multicenter, open-label extension clinical trial to assess the efficacy, tolerance and safety of Rotigotine, administered in subcutaneous patches, in patients with advanced Parkinson’s disease.

– SCHWARZ PHARMA: SP 515. Multicenter, randomized, double-blind, placebo- and Pramipexole-controlled clinical trial to evaluate the efficacy, tolerance and safety of Rotigotine, administered in subcutaneous patches, in patients with advanced Parkinson’s disease.

– NOVARTIS: CENA 713-IA 05. Prospective, multicenter, randomized, double-blind, placebo-controlled and parallel group study of 24 weeks duration, to test the efficacy, tolerability and safety of 3-12 mg/day of Exelon (Rivastigmine) in capsules, in patients with probable vascular dementia.

– NOVARTIS: 713-B2311 E1 (DINNER). Clinical Trial 24-Week Open-Label Extension Study: A 24-week, prospective, randomized, double-blind, parallel, placebo-controlled, multicenter study to assess the efficacy, tolerability, and safety of 3-12 mg/ day of Exelon (Rivastigmine) in capsules, in patients with dementia due to Parkinson’s Disease.

– NOVARTIS: DINNER 713-B2311. Multicenter, prospective, randomized, double-blind, parallel and placebo controlled study, of 24 weeks duration, to evaluate the efficacy, tolerability and safety of 3-12 mg/day of Exelon (Rivastigmine) in capsules, in patients with dementia due to Parkinson’s disease.

– NOVARTIS: CCOM998 IA04. Multicenter, open-label study to evaluate different dose regimens of the combination levodopa / DDCI / entacapone, in patients with Parkinson’s disease who begin to experience symptoms of end-of-dose deterioration.

– SCHERING AG: Continuous subcutaneous administration (12h/24h) in advanced Parkinson’s disease with complex fluctuations and dyskinesias, by Lisuride subcutaneous infusion pump. 1987-1988. Research collaborator. Principal investigator Dr. E. Tolosa. Hospital Clinic (Barcelona). Phase II (proof of concept).

Alzheimer disease

–EISAI: BAN2401-G000-201 OLE
A Double-Blind, Parallel-Group, Placebo-Controlled, Bayesian Adaptive Randomization Design, Dose Regimen-Searching Study with an Open-Label Extension Phase to Evaluate the Safety, Tolerability, and Efficacy of BAN2401 in Subjects with Early Alzheimer’s Disease.

–LILLY: J1G-MC-LAKD. (TRAILRUNNER-ALZ 2). Assessment of safety and efficacy of subcutaneous remternetug in early symptomatic Alzheimer’s disease. Compound: Remternetug (LY3372993). Study Phase: 3.

–BIAL: BIA 28-6156-201. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIA 28 6156 in Subjects With Parkinson’s Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene.

–NEURIMMUNE: NI004-201. A phase 1b/2a, multicenter, randomized, parallel group, double-blind, placebo-controlled clinical trial to assess the safety, tolerability, and efficacy of M1 (ortosteric selective) muscarinic agonist NI004 compared to placebo in mild Alzheimer’s disease to moderate.

–ABBVIE: M22-721 (HARBOR)
Protocol for Study M22-721 Alzheimer’s Disease: A Phase 1b/2a Multiple Ascending Dose and Proof-of-Concept Study of ABBV-916.

–AVANIR: 20-AVP-786-307 (ASPECT)
A phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide /quinidine sulfate) for the treatment of agitation in patients with dementia of the Alzheimer type.

–TauRx Therapeutics: TRx-237-039 (LUCIDITY).
A 9-month, three-arm, randomized, double-blind, placebo-controlled study of brain imaging and the safety and efficacy of LMTM in subjects with early Alzheimer’s disease.

–ROCHE: WN29922 (GRADUATE).
A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of gantenerumab in patients with early Alzheimer’s disease.

–CORTEXYME: COR388-010 (GAIN). A randomized, double-blind, placebo-controlled study of COR388HCI in subjects with Alzheimer’s disease.

– ACADIA: ACP-103-045. A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis.

– BOEHRINGER-INGELHEIM: 1346.23 A multi-centre, double-blind, parallel-group, randomized controlled study to investigate efficacy, safety and tolerability of orally administered BI 425809 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer’s Disease. PI: Dr. E. Balaguer. General University Hospital of Catalonia. PI: Dr. A. Hernández. Sant Joan de Déu Hospital, Manresa.

– EISAI: E2609-G000-301 (MISSION AD). A Placebo-Controlled, Double-Blind, Parallel-Group, 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects with Early Alzheimer’s Disease.

– HEPTARES. HTL0018318-202. A phase 1b randomized, double-blind, placebo-controlled, parallel group, multi-center study to determine the safety and tolerability of HTL0018318 in subjects with mild to moderate Alzheimer’s disease receiving donepezil or donepezil / memantine.

– JANSSEN: 54861911ALZ2003 (EARLY). A phase II b / III randomized, double-blind, placebo-controlled, parallel group, multicenter study investigating the efficacy and safety of JNJ-54861911 in subjects who are asymptomatic at risk for developing Alzheimer’s Dementia. PI: Dr. A. Ugarte. Sant Joan de Déu Hospital, Manresa.

– AXOVANT: RVT-101-3002. Open Label extension of a phase 3, double-blind, randomized study of RVT-101 versus placebo when added to existing stable donepezil treatment in subjects with mild to moderate Alzheimer’s disease.

– AXOVANT: RVT-101-3001. A Phase 3, double-blind, randomized study of RVT-101 versus placebo when added to existing stable donepezil treatment in subjects with mild to moderate Alzheimer’s disease.

– ROCHE: BN40031 (CREAD OLE). Multicenter, open-label, long-term extension study of Phase III studies (BN29552/BN29553) of Crenezumab (RO5490245) in patients with mild Alzheimer’s disease.

– ROCHE: BN 29553 (CREAD2). Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Crenezumab (RO5490245) in patients with mild Alzheimer’s disease.

– ROCHE: BN 29552 (CREAD). Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Crenezumab (RO5490245) in patients with mild Alzheimer’s disease.

– BIOGEN: 221AD301 (EMERGE). Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Patients With Early Alzheimer’s Disease. PI: Dr. A. Ugarte. Sant Joan de Déu Hospital, Manresa.

– LILLY/ASTRAZENECA: I8D-MC-AZET (DAYBREAK). Randomized, double-blind, placebo-controlled, delayed-start study of LY3314814/AZD3293 in mild Alzheimer’s disease dementia.

– ASTRAZENECA/LILLY: AZD3293 (AMARANTH). A 24-month, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy, safety, tolerability, biomarkers, and pharmacokinetics of AZD3293/LY3314814 in early-stage Alzheimer’s disease. 2015-2017. PI: Dr. A. Ugarte. Sant Joan de Déu Hospital, Manresa.

– BOEHRINGER INGELHEIM: 1289.5. Multicenter, double-blind, randomized controlled parallel group study to investigate the efficacy, safety, and tolerability of BI 409306, administered orally over a 12-week treatment period, compared to placebo in patients with Alzheimer’s disease.

– LILLY: H8A-MC-LZAX. Effect of passive immunization on the progression of mild Alzheimer’s disease Solanezumab (LY2062430) versus placebo. PI: Dr. A. Ugarte. Sant Joan de Déu Hospital, Manresa.

– GRIFOLS: IG1002 (AMBER). Multicenter, randomized, controlled study to evaluate the efficacy and safety of short-term plasma exchange followed by long-term plasmapheresis with infusions of human albumin combined with intravenous immunoglobulin in patients with mild-moderate Alzheimer’s disease.

– LUNDBECK: LU14863. Phase 3, multicenter, randomized, double-blind, comparative, placebo-controlled, parallel-group clinical study to evaluate the efficacy and safety of Lu AE58054 in patients with mild-to-moderate Alzheimer’s disease treated with acetylcholinesterase inhibitors. PI: Dr. A. Ugarte. Sant Joan de Déu Hospital, Manresa. PI: Dr. E. Balaguer. General Hospital of Catalonia.

– LUNDBECK: LU14861B / Memantine. Open and Memantine Extension of Trial 14861A. 2015-2016. Collaborating researcher. PI: Dr. A. Ugarte. Sant Joan de Déu Hospital, Manresa. PI: Dr. E. Balaguer. General Hospital of Catalonia.

– LUNDBECK: LU14861A. Randomized, double-blind, parallel-group, placebo-controlled, fixed-dose study of Lu AE 58054 in patients with mild or moderate Alzheimer’s disease treated with Donepezil. PI: Dr. A. Ugarte. Sant Joan de Déu Hospital, Manresa. PI: Dr. E. Balaguer. General Hospital of Catalonia.

– LUPIN: LRP/LND101001. A Randomized, Double-blind, Placebo-controlled, Parallel Group, Comparative, Multicenter, Phase 2 Clinical Study to Evaluate Efficacy and Safety of Two Doses of LND101001 Monotherapy in Patients with Mild to Moderate Alzheimer’s Disease.

– EISAI: BAN2401-G000-201. Bayesian adaptive randomization, double-blind, parallel-group, placebo-controlled dosage regimen study to evaluate the safety, tolerability, and efficacy of BAN2401 in subjects with early-onset Alzheimer’s disease.

– SERVIER: CL2-38093-012. Phase IIb, multicenter, randomized study to investigate the efficacy and safety of 3 doses of S38093 (2, 5 and 20 mg/day) versus placebo, associated with Donezepil (10 mg/day) in patients with moderate Alzheimer’s disease.

– ROCHE: BP 28248. Phase III, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the efficacy and safety of RO4602522 added to background treatment with acetylcholinesterase inhibitors, Donezepil or Rivastigmine, in patients with moderate-intensity Alzheimer’s disease.

– GENENTECH/ROCHE: GN 28525. Open-label extension study to evaluate the efficacy and safety of MABT5102A in patients with mild or moderate Alzheimer’s disease.

– LILLY: 140-MC-BACC. Evaluation of the safety, tolerability, and pharmacodynamic effects of LY2886721 in patients with mild cognitive impairment due to Alzheimer’s disease or with mild Alzheimer’s disease.

– GENENTECH/ROCHE: GN ABE 4869g. Multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial to evaluate the efficacy and safety of MABT5102A in patients with mild to moderate Alzheimer’s disease.

– NOVARTIS: CAD106 A2203. Multicenter, randomized, double-blind, placebo-controlled, 90-week, adaptive-design clinical trial in patients with mild Alzheimer’s disease to investigate the safety, tolerability, and response of specific anti-AB antibodies after repeated intramuscular administration of CAD106 with adjuvant.

– GSK: AVA 105640. A 36-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE ε4-stratified subjects with mild to moderate Alzheimer’s disease. PI: Dr. L. Soler. General Hospital of Catalonia.

– NOVARTIS: CENA713-ES-02. Pilot, multicenter, randomized, double-blind, controlled, parallel study to evaluate the efficacy and safety of Rivastigmine versus placebo in the treatment of cognitive and non-cognitive symptoms in patients with moderate-severe Alzheimer’s disease.

Progressive Supranuclear Palsy

– Alfa Bioresearch: AB 13004. A prospective, multicenter, randomized, double-blind, placebo-controlled, parallels groups phase IIb / III study to compare the efficacy and safety of Masitinib versus placebo in the treatment of patients suffering from Progressive Supranuclear Palsy.

– BRISTOL MYERS SQUIB/BIOGEN. CN 002-012 / 251PP301 (PASSPORT). Randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of intravenously administered BMS 986168 in patients with Progressive Supranuclear Palsy with an open extension.

– UCB: PSP003. A Participant-Blind, Investigatir Blind, Placebo-Controlled, Phase IB Study to evaluate the safety, tolerability, and pharmacokinetics of UCB0107 in study participants with Progressive Supranuclear Palsy (PSP).

X fragile syndrome

– NOVARTIS: CAFQ056-A2212. Double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of AFQ056 in adult patients with Fragile Syndrome.

– NOVARTIS: CAFQ056-B2214. Double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy and safety of AFQ056 in adolescent patients with Fragile X Syndrome.

– NOVARTIS: CAFQ056-B2279. Open-label extension study to evaluate the safety, efficacy, and tolerability of AFQ056 in adult patients with Fragile X Syndrome.

– NOVARTIS: CAFQ056-B2278. Open-label extension study to evaluate the safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome.

– NOVARTIS CAFQ056-B2154. A sequential phase I with 2 periods to evaluate the pharmacokinetics, safety and tolerability of an oral single dose or multiple oral doses of AFQ056 in patients with Fragile X Syndrome, between 5 and 11 years of age (Cohort 1) and between 3 and 4 years of age (Cohort 2).

– ROCHE: NP27936. Phase II, randomized, double-blind, placebo-controlled parallel group study to investigate the efficacy and safety of RO4917523 in patients with Fragile X Syndrome.

Multiple sclerosis

– NURON: NU-100-101. Phase III multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis

– NOVARTIS: CFTY 720 D2402. Phase II, double-blind, randomized, double-blind, multicenter study of parallel groups that studies the structural changes in the retina and the evolution of visual function after immediate versus delayed treatment with fingolimod in patients with acute demelianizing optic neuritis.

Epilepsy

– BIAL: IMDYVA study (Impact of Depression and quality of Life). Epidemiological study of depression in patients with focal epilepsy and its impact on quality of life.

– BIAL: BIA 2093-311. Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Monotherapy for Newly Diagnosed Patients with Partial-Onset Seizures: Double-Blind, Randomized, Active-Drug, Parallel-Group, Multicenter Study. PI: Dr. E. Balaguer. General Hospital of Catalonia. PI: Dr A. Ugarte. Hospital Sant Joan de Déu, Manresa, Fundació Althaia.

– UCB: SP 0980. Efficacy and Safety of Lacosamide in drug-resistant epilepsy. PI: Dr A. Ugarte. Hospital Sant Joan de Déu, Manresa, Fundació Althaia.

Cerebral vascular disease

– ASTRA: CLASS (Clomethiazol Acute Stroke Study). Neuroprotection with clomethiazole, double-blind, placebo-control, in acute stroke, from 6 to 12 hours of evolution. PI: Dr. L. Soler. General Hospital of Catalonia.

– URIACH: TACIP. Trifusal versus acetylsalicylic acid in the secondary prevention of ischemic stroke. PI: Dr. L. Soler. General Hospital of Catalonia.

Restless Leg Syndrome

– BOEHRINGER-INGELHEIM: BI 248.604. Randomized study to evaluate the efficacy and safety of pramipexole versus placebo in restless legs syndrome and mood disorders.

– BOEHRINGER-INGELHEIM: BI 248.615. Randomized study to evaluate the efficacy and safety of Pramipexole versus placebo in restless legs syndrome and sleep disturbance.

Tourette síndrome

– BOEHRINGER-INGELHEIM: BI 248.641. A Phase III double-blind, double-dummy, placebo-controlled, 8-week fixed-dose trial with pramipexole IR 0.125 and 0.5 mg/day administered orally to investigate the efficacy and safety in patients 6-17 years of age diagnosed with Tourette Syndrome according to DSM-IV criteria.

– OTSUKA: 12-31-293. Multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of aripiprazole administered in fixed doses orally once daily in children and adolescents with Gilles de la Tourette syndrome.

Non-neurological clinical trials

– COSMO/CROSS: CRO-16-130 S (CB-01-11/28). A Phase II, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study of the efficacy and safety of Rifamycin SV-MMX® 600 mg tablets administered three or twice daily to patients with bowel syndrome irritable with predominant diarrhea. PI: Dr. E. Saperas. General Hospital of Catalonia.

– LEON FARMA: CF 111/302. Phase III pivotal, multicenter, double-blind, double-masked, randomized study to compare the contraceptive efficacy, tolerability and safety of LF111 (Drospirenone) for 9 cycles with Cerazette (Desogestrel 0.075 mg). November 2012- June 2013. Collaborating researcher and management. General Hospital of Catalonia.

–NOVARTIS: CLCZ696B2320 (PERSPECTIVE). Multicenter, randomized, double-blind, active-controlled study to evaluate the effects of LCZ696 compared to Valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction. General Hospital of Catalonia.

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