Effect of a 15-day Donepezil Treatment on Biomarkers of AD in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Pharmacog battery
Study Overview
Brief Summary
The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs
Detailed Description
The aim of the present study is to test the effect of a 15-day treatment with donepezil on a mixed battery associating cognitive assessment, imaging and neurophysiological tests in healthy volunteers.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18-30 year old male non-smoker subjects
- •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 age < 18 years or > 30 years
- •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
Arms & Interventions
Donepezil
Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
Intervention: Donepezil . (Drug)
Placebo
The placebo will be presented as tablet comparable to ARICEPT
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Pharmacog battery
Time Frame: 15 days
* cognitive tests (8 items of the Cantab battery) : * Motor screening * 4 tests for visual memory (Delayed Matching to Sample, Paired Associated Learning, Pattern Recognition Memory, Spatial Recognition Memory) * 1 test for executive functions (Spatial Working Memory) * 2 tests for attention (Reaction Time, Rapid Visual Information Processing) * completed by a modified ADNI battery : ADAScog * imaging * fMRI * PET-FDG * neurophysiological * EEG
Secondary Outcomes
No secondary outcomes reported