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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Lille
• Collaborator: Innovative Medicines Initiative
• Treatments: Donepezil

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