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

NCT01487395 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-04-09

No results posted yet for this study

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

Conditions

  • Alzheimer Disease
  • Battery

Interventions

DRUG

Donepezil .

Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.

DRUG

Placebo

the placebo will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.

Sponsors & Collaborators

  • Innovative Medicines Initiative

    collaborator OTHER

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Régis Bordet, MD PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-12-31
Completion
2013-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01487395 on ClinicalTrials.gov