Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development
NCT ID: NCT01487395
Last Updated: 2015-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2011-12-31
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prediction of Cognitive Properties of Memantine for Neurodegenerative Diseases
NCT02288000
The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil
NCT01024660
Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)
NCT02064920
Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-
NCT01129596
Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413)
NCT04730635
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This multicenter, randomized, placebo-controlled, cross-over study is double-blind controlled and is conducted in 3 centers located in France (Lille, Marseille and Toulouse).
18-30 years old, healthy volunteers, without any neurological or psychiatric impairment, will complete 2 test sessions in a randomized order: one with a 15-day treatment with donepezil, the other with placebo, and will be submitted to a mixed battery during the 14th and 15th day of the treatment. The primary outcome of the study will be based on cognitive assessment, imaging parameters and neurophysiological parameters.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Donepezil
Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
Donepezil .
Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
Placebo
The placebo will be presented as tablet comparable to ARICEPT
Placebo
the placebo will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Donepezil .
Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
Placebo
the placebo will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject without cognitive impairment or cognitive complaint (Moca\>26, Mac Nair scale\<15)
* Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor,…)
* Subject without major medical or surgical history
* Subject without current chronic disease
* Subject without current cerebral disease
* Subject without vascular or metabolic risk factor
* Subject without history or current mental disease or addiction (MINI)
* Subject without lesion on MRI
* Subject without abnormal electrical activities on EEG
* Subject without use of chronic treatment or psychotropic drugs or substances
* French speaker subject and able to understand the test instructions
Exclusion Criteria
* Subject with dementia or cognitive decline identified by Moca \< 26
* Subject with history of brain disease (brain trauma, stroke, cerebral tumor,…)
* Subject with major medical or surgical history
* Subject with current chronic disease
* Subject with current cerebral disease
* Subject with vascular or metabolic risk factor
* Subject with history or current mental disease or addiction
* Subject with family history of young-onset dementia
* Subject with family history of chronic or severe neurological or mental disease (first degree relatives)
* Subject with lesion on MRI
* Subject with abnormal electrical activities on EEG
* Subject receiving a chronic treatment
* Subject using chronically or acutely psychotropic drugs or substances
* Subject with claustrophobia or contra-indication to MRI
* Subject unable to understand the test instructions
18 Years
30 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Innovative Medicines Initiative
OTHER
University Hospital, Lille
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Régis Bordet, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHRU de Lille/ Centre d'investigation Clinique
Lille, , France
CIC Marseille
Marseille, , France
CIC Toulouse
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-023989-51
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2010_41
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.