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Alzheimer and Sleep

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Galantamine and Donepezil
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring sleep, Alzheimer, old patients

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand
  • CPC-CIC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Galantamine

Arm Description

Outcomes

Primary Outcome Measures

Comparison of the percentage of paradoxical sleep recorded with polysomonography in 65 years old patients with administration of Galantamine or Donépézil

Secondary Outcome Measures

Describe the iatrogenic modifications of rhythm and architecture of sleep. describe the iatrogenic modifications of rythm and architecture of sleep

Full Information

First Posted
September 9, 2008
Last Updated
July 4, 2014
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Janssen-Cilag Farmaceutica Ltda.
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1. Study Identification

Unique Protocol Identification Number
NCT00750529
Brief Title
Alzheimer and Sleep
Official Title
Effects of Galantamine and Donépézil on the Amount and the Quality oh the Sleep in Patients Suffering From Alzheimer Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Janssen-Cilag Farmaceutica Ltda.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
sleep, Alzheimer, old patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Galantamine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Galantamine and Donepezil
Intervention Description
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
Primary Outcome Measure Information:
Title
Comparison of the percentage of paradoxical sleep recorded with polysomonography in 65 years old patients with administration of Galantamine or Donépézil
Time Frame
administration of galantamine or donépézil
Secondary Outcome Measure Information:
Title
Describe the iatrogenic modifications of rhythm and architecture of sleep. describe the iatrogenic modifications of rythm and architecture of sleep
Time Frame
during the iatrogenic modifications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dubray Claude, Pr
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CPC-CIC
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

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Alzheimer and Sleep

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