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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease; Battery	Drug: Donepezil .; Drug: Placebo	Phase 1

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Effect of a 15-day Donepezil Treatment on Biomarkers of AD in Healthy Volunteers
Study Start Date :	December 2011
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2013

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Donepezil; Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.	Drug: Donepezil .; Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.; Other Names: ARICEPT ® Donépezil; Orally Disintegrating Tablets (ODT): 5 mg.
Placebo Comparator: Placebo; The placebo will be presented as tablet comparable to ARICEPT	Drug: Placebo; the placebo will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.

Outcome Measures

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Primary Outcome Measures :

1. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 30 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Locations

France
CHRU de Lille/ Centre d'investigation Clinique
Lille, France, 59037
CIC Marseille
Marseille, France
CIC Toulouse
Toulouse, France

Sponsors and Collaborators

University Hospital, Lille

Innovative Medicines Initiative

Investigators

Principal Investigator:	Régis Bordet, MD PhD	University Hospital, Lille

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT01487395 History of Changes
Other Study ID Numbers:	2010_41; 2010-023989-51 ( EudraCT Number )
First Posted:	December 7, 2011
Last Update Posted:	April 9, 2015
Last Verified:	April 2015

Keywords provided by University Hospital, Lille:

Alzheimer; Donepezil; biomarkers; battery	cognition; imaging; neurophysiological

Additional relevant MeSH terms:

Alzheimer Disease; Neurodegenerative Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders	Donepezil; Cholinesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Nootropic Agents