Alzheimer and Sleep

NCT ID: NCT00750529

Last Updated: 2014-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-09-30

Brief Summary

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The aim of the study is the analysis of two inhibitors of Ach-E: galantamine and donépézil in over 65 years' old patients suffering from Alzheimer disease (MMSE between 20 and 26) without Alzheimer's medication.

Detailed Description

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Feasibility study, open, randomized, controlled, cross-over study in 65 years old patients.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Galantamine

Group Type EXPERIMENTAL

Galantamine and Donepezil

Intervention Type DRUG

the analysis of two inhibitors of Ach-E : galantamine and donézepil in over 65 years old patients suffering from Alzheimer's disease (MMSE between 20 and 26) without Alzheimer's medication

Interventions

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Galantamine and Donepezil

the analysis of two inhibitors of Ach-E : galantamine and donézepil in over 65 years old patients suffering from Alzheimer's disease (MMSE between 20 and 26) without Alzheimer's medication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 65 and over years old
* Patients suffering from Alzheimer disease
* Patient living with someone at home
* Written consent given

Exclusion Criteria

* Galantamine or Donepezil hypersensibility
* Patient living alone and in a medicalized structure
* Concomitant medication
* Chronical diseases
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag Farmaceutica Ltda.

INDUSTRY

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dubray Claude, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

CPC-CIC

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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CHU-0038

Identifier Type: -

Identifier Source: org_study_id

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