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

Primary Purpose

Alzheimer Disease, Battery

Status

Completed

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

Donepezil .

Placebo

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer, Donepezil, biomarkers, battery, cognition, imaging, neurophysiological

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Donepezil

Placebo

Arm Description

Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.

The placebo will be presented as tablet comparable to ARICEPT

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01487395

First Posted

December 5, 2011

Last Updated

April 8, 2015

Sponsor

University Hospital, Lille

Collaborators

Innovative Medicines Initiative

1. Study Identification

Unique Protocol Identification Number

NCT01487395

Brief Title

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

Acronym

PharmacogWP3

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

Collaborators

Innovative Medicines Initiative

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, Battery

Keywords

Alzheimer, Donepezil, biomarkers, battery, cognition, imaging, neurophysiological

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Donepezil

Arm Type

Active Comparator

Arm Description

Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

The placebo will be presented as tablet comparable to ARICEPT

Intervention Type

Drug

Intervention Name(s)

Donepezil .

Other Intervention Name(s)

ARICEPT ® Donépezil, Orally Disintegrating Tablets (ODT): 5 mg.

Intervention Description

Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

the placebo will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.

Primary Outcome Measure Information:

Title

Pharmacog battery

Description

Time Frame

15 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Régis Bordet, MD PhD

Organizational Affiliation

University Hospital, Lille

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHRU de Lille/ Centre d'investigation Clinique

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

CIC Marseille

City

Marseille

Country

France

Facility Name

CIC Toulouse

City

Toulouse

Country

France

12. IPD Sharing Statement

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

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