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Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development (PharmacogWP3)
This study has been completed.
Sponsor:
University Hospital, Lille
Collaborator:
Innovative Medicines Initiative
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01487395
First received: December 5, 2011
Last updated: April 8, 2015
Last verified: April 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Alzheimer Disease Battery | Drug: Donepezil . Drug: Placebo | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of a 15-day Donepezil Treatment on Biomarkers of AD in Healthy Volunteers |
Resource links provided by NLM:
Further study details as provided by University Hospital, Lille:
Primary Outcome Measures:
- 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
-
| Enrollment: | 30 |
| Study Start Date: | December 2011 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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.
|
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| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487395
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487395
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
| Responsible Party: | University Hospital, Lille |
| ClinicalTrials.gov Identifier: | NCT01487395 History of Changes |
| Other Study ID Numbers: |
2010_41 2010-023989-51 ( EudraCT Number ) |
| Study First Received: | December 5, 2011 |
| Last Updated: | April 8, 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 |
ClinicalTrials.gov processed this record on July 21, 2017