NCT00750529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

4.8 years

First QC Date

September 9, 2008

Last Update Submit

July 4, 2014

Conditions

Alzheimer's Disease

Keywords

sleepAlzheimerold patients

Outcome Measures

Primary Outcomes (1)

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

    administration of galantamine or donépézil

Secondary Outcomes (1)

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

    during the iatrogenic modifications

Study Arms (1)

Galantamine

EXPERIMENTAL
Drug: Galantamine and Donepezil

Interventions

Galantamine and DonepezilDRUG

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

Galantamine

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Galantamine or Donepezil hypersensibility
  • Patient living alone and in a medicalized structure
  • Concomitant medication
  • Chronical diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

CPC-CIC

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

GalantamineDonepezil

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae AlkaloidsAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingPolycyclic Compounds

Study Officials

  • Dubray Claude, Pr

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2008

First Posted

September 10, 2008

Study Start

November 1, 2008

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

FR(2)