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

NCT01487395 | Completed Phase 1

• 2 other identifiers: 2010_412010-023989-51
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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 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

Keywords

Alzheimer; Donepezil; biomarkers; battery; cognition; imaging; neurophysiological

Outcome Measures

Primary Outcomes (1)

• Pharmacog battery

  * 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

  15 days

Study Arms (2)

Donepezil

ACTIVE COMPARATOR

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

Drug: Donepezil .

Placebo

PLACEBO COMPARATOR

The placebo will be presented as tablet comparable to ARICEPT

Drug: Placebo

Interventions

Donepezil . DRUG

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

Also known as: ARICEPT ® Donépezil, Orally Disintegrating Tablets (ODT): 5 mg.

Donepezil

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Innovative Medicines Initiative: collaborator

Study Sites (3)

CHRU de Lille/ Centre d'investigation Clinique

Lille, 59037, France

Location

CIC Marseille

Marseille, France

Location

CIC Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Régis Bordet, MD PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 7, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

FR (3)