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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:
ClinicalTrials.gov Identifier:
NCT01487395
First Posted: December 7, 2011
Last Update Posted: April 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Innovative Medicines Initiative
Information provided by (Responsible Party):
University Hospital, Lille
December 5, 2011
December 7, 2011
April 9, 2015
December 2011
December 2012   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01487395 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development
Effect of a 15-day Donepezil Treatment on Biomarkers of AD in Healthy Volunteers
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

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Alzheimer Disease
  • Battery
  • 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.
  • Drug: Placebo
    the placebo will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
  • Active Comparator: Donepezil
    Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
    Intervention: Drug: Donepezil .
  • Placebo Comparator: Placebo
    The placebo will be presented as tablet comparable to ARICEPT
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2013
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 30 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01487395
2010_41
2010-023989-51 ( EudraCT Number )
No
Not Provided
Not Provided
University Hospital, Lille
University Hospital, Lille
Innovative Medicines Initiative
Principal Investigator: Régis Bordet, MD PhD University Hospital, Lille
University Hospital, Lille
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP