We are developping a clinical trial that evaluates the efficacy and safety of an oral medication that inhibits an enzyme released by a dental germ in patients with moderate Alzheimer’s disease.
The GAIN trial (code COR388-010) is a phase III clinical trial and we are carrying out in Spain, in the General University Hospital of Catalonia, with the collaboration between the services of neurology, neuropsychology, neuroradiology and odontology, coordinated by Dr. Balaguer, neurologist and director of research.
– Dr. Balaguer, scientific director of the UDIC, has directed the course of Coordination and Practical Management of clinical trials in Neurology (module from 5:30 hours). Completed during the LXX Annual Meeting of the Spanish Society of Neurology (Seville, 24 November 2018).
– Continue the development of our projects in Parkinson’s disease: anti-alfasinuclein monoclonal antibodies, gastric-retention levodopa, antidiscinetic drug in advanced Parkinson’s, new drug against hallucinations and delusions in Parkinson’s disease dementia.
– UDIC is performing several clinical trials in Alzheimer’s disease: oral drug acting like inhibitor of amyloid, anti-amyloid monoclonal antibodies (intravenously and subcutaneously), neuromodulator drug in moderated Alzheimer’s disease.
– Many patients still are taking part in a study in Progressive Supranuclear Paralysis with an anti-tau monoclonal antibodies.
The Hospital Universitari General de Catalunya appoints Dr. Balaguer as the new Research Director on June 12, 2013.
Drugs authorized in our country or approved by the FDA, which were evaluated by the UDIC: Rivastigmine (Exelon), Entacapone (Comtan), Rotigotine (Neupro), Pramipexol ER (Mirapexin LP), Ropinirol ER (Requip LP) Safinamide (Xadago) , Opicapona (Ongentys), Pimavanserin (Nuplazid), CVT 301 (..)
Visit of Dr. Chris Kenney: The Medical Director of ACORDA, holder of CVT 301 (Levodopa inhaled) and Tozadenant came to our facilities during his visit to our country. The UDIC was a pioneer and main recruiter of patients in both clinical trials.
Audits and Inspections:
Random inspection FDA: In 2009 our Unit got over unqualified a random inspection of Spanish centers that had participated in a clinical trial in Parkinson’s disease.
The UDIC has passed frequent national and international audits, carried out in general due to its high rate of patient inclusion. During the year 2017, international audits of one trial in Parkinson’s disease and another in Alzheimer’s disease were developed, with satisfactory results.
– Our Unit has been the first center in our country to start two new trials: antidiscinetic in phase II in Parkinson’s, and Alzheimer’s (muscarinic agonist, phase Ib).
– We are the first center, with the largest number of patients included, in the new trial in Progressive Supranuclear Paralysis
– First Spanish recruiting center in a trial with a new drug in Alzheimer’s.
The prestigious scientific journal NATURE has published a Phase II trial with a monoclonal anti-amyloid antibody (aducanumab) in Alzheimer’s disease, with a positive result. The UDIC participates in the development of Phase III of this project, in the EMERGE trial.
-Trial of Solanezumab for Mild Dementia Due to Alzheimer’s Disease.
Lawrence S.H onig, Bruno Vellas, Michael Woodward, Mercè Boada et al.
N Engl J Med 2018; 378:321-330. January 25, 2018
–Dr Balaguer en La Vanguardia.
The scientific community continues to work in the search for solutions to Alzheimer’s. Researchers shed a light of hope at the negative result of the large clinical trial with solanezumab