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

Alzheimer Disease Clinical Trial

— PharmacogWP3  

Official title:

Effect of a 15-day Donepezil Treatment on Biomarkers of AD in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487395
• Other study ID #: 2010_41
• Secondary ID: 2010-023989-51
• Status: Completed
• Phase: Phase 1
• First received: December 5, 2011
• Last updated: April 8, 2015
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Battery
• Neurodegenerative Diseases

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	CHRU de Lille/ Centre d'investigation Clinique	Lille
France	CIC Marseille	Marseille
France	CIC Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Innovative Medicines Initiative

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacog battery	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	15 days	Yes