Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development (PharmacogWP3)

University Hospital, Lille

Status and phase

Completed

Phase 1

Conditions

Battery

Alzheimer Disease

Treatments

Drug: Donepezil .

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01487395

2010-023989-51 (EudraCT Number)

2010_41

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

Male

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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