Prediction of Cognitive Properties of New Drug Candidates... | NCT01487395

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

NCT01487395

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Apr 9, 2015Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Alzheimer Disease
Battery

Interventions

Donepezil .
Placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-023989-51	EudraCT Number

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2013Actual

First Submitted Date

Dec 5, 2011

First Submission Date that Met QC Criteria

Dec 6, 2011

First Posted Date

Dec 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2015

Last Update Posted Date

Apr 9, 2015Estimated

Name	Class
Innovative Medicines Initiative	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

This multicenter, randomized, placebo-controlled, cross-over study is double-blind controlled and is conducted in 3 centers located in France (Lille, Marseille and Toulouse).

18-30 years old, healthy volunteers, without any neurological or psychiatric impairment, will complete 2 test sessions in a randomized order: one with a 15-day treatment with donepezil, the other with placebo, and will be submitted to a mixed battery during the 14th and 15th day of the treatment. The primary outcome of the study will be based on cognitive assessment, imaging parameters and neurophysiological parameters.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Donepezil .	Drug	Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.	Donepezil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Lille/ Centre d'investigation Clinique		Lille		59037	France
CIC Marseille

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D007189	Indans
D007192	Indenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic