Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development (PharmacogWP3)
This study is currently recruiting participants.
Verified October 2011 by University Hospital, Lille
Sponsor:
University Hospital, Lille
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01487395
First received: December 5, 2011
Last updated: March 19, 2012
Last verified: October 2011
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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 Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
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
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated 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.
Other Name: placebo
|
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 |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487395
Contacts
| Contact: Régis Bordet, MD PhD | +333 20 44 54 49 | regis.bordet@univ-lille2.fr |
| Contact: Aurélie Gozdziaszek, CRA | +333 20 44 41 45 | aurelie.gozdziaszek@chru-lille.fr |
Locations
| France | |
| CHRU de Lille/ Centre d'investigation Clinique | Recruiting |
| Lille, France, 59037 | |
| Contact: Dominique Deplanque, PH dominique.deplanque@chru-lille.fr | |
| Principal Investigator: Régis Bordet, MD PhD | |
| CIC Marseille | Not yet recruiting |
| Marseille, France | |
| Contact: Olivier Blin olivier.blin@ap-hm.fr | |
| CIC Toulouse | Not yet recruiting |
| Toulouse, France | |
| Contact: Olivier Rascol cic9302@purpan.inserm.fr | |
Sponsors and Collaborators
University Hospital, Lille
Investigators
| Principal Investigator: | Régis Bordet, MD PhD | University Hospital, Lille |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Lille |
| ClinicalTrials.gov Identifier: | NCT01487395 History of Changes |
| Other Study ID Numbers: | 2010-023989-51 |
| Study First Received: | December 5, 2011 |
| Last Updated: | March 19, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Lille:
|
Alzheimer Donepezil biomarkers battery |
cognition imaging neurophysiological |
Additional relevant MeSH terms:
|
Neurodegenerative Diseases Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil |
Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013