Overview

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