Status:
COMPLETED
Prediction of Cognitive Properties of New Drug Candidates for Neurodegenerative Diseases in Early Clinical Development
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Innovative Medicines Initiative
Conditions:
Alzheimer Disease
Battery
Eligibility:
MALE
18-30 years
Phase:
PHASE1
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 de...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01487395
Start Date
December 1 2011
End Date
December 1 2013
Last Update
April 9 2015
Active Locations (3)
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1
CHRU de Lille/ Centre d'investigation Clinique
Lille, France, 59037
2
CIC Marseille
Marseille, France
3
CIC Toulouse
Toulouse, France