Clinical trial NCT01487395: Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development
Official title: Effect of a 15-day Donepezil Treatment on Biomarkers of AD in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Battery
Keywords: Alzheimer
Donepezil
biomarkers
battery
cognition
imaging
neurophysiological
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Innovative Medicines Initiative
First posted: 2011-12-07
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacog battery
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU de Lille/ Centre d'investigation Clinique
city: Marseille
country: France
facility: CIC Marseille
city: Toulouse
country: France
facility: CIC Toulouse
Study officials:
affiliation: University Hospital, Lille
name: Régis Bordet, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: