Alzheimer's DiseasePhase 1NCT00750529
Alzheimer and Sleep
A Phase 1 study testing Galantamine and Donepezil in people with Alzheimer's Disease, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Galantamine and Donepezil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2008to Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 and over years old
- Patients suffering from Alzheimer disease
- Patient living with someone at home
- Written consent given
Who cannot join
- Galantamine or Donepezil hypersensibility
- Patient living alone and in a medicalized structure
- Concomitant medication
- Chronical diseases
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
CPC-CIC
Clermont-Ferrand, 63003
About this study
Official title: Effects of Galantamine and Donépézil on the Amount and the Quality oh the Sleep in Patients Suffering From Alzheimer Disease.
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.
Read the detailed description
Feasibility study, open, randomized, controlled, cross-over study in 65 years old patients.
- Conditions
- Alzheimer's Disease
- Being tested
- Galantamine and Donepezil
- Keywords
- sleep, Alzheimer, old patients
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Galantamine | Experimental | Not described Receives: Drug: Galantamine and Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the percentage of paradoxical sleep recorded with polysomonography in 65 years old patients with administration of Galantamine or Donépézil
Measured: 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
Measured: during the iatrogenic modifications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Farmaceutica Ltda.
- Responsible party
- Sponsor
- Investigators
- Dubray Claude, Pr, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750529
- Sponsor's protocol ID
- CHU-0038
- Status last verified
- Jul 2014
- First submitted
- 9 Sep 2008
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Galantamine and Donépézil on the Amount and the Quality oh the Sleep in Patients Suffering From Alzheimer Disease.
- ClinicalTrials.gov ID
- NCT00750529
- Acronym / sponsor ID
- CHU-0038
- Conditions
- Alzheimer's Disease
- Keywords
- sleep, Alzheimer, old patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Janssen-Cilag Farmaceutica Ltda.
- Study start
- Nov 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Galantamine | Experimental | Drug: Galantamine and Donepezil |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 and over years old
- Patients suffering from Alzheimer disease
- Patient living with someone at home
- Written consent given
Key exclusion criteria (4 listed)
- Galantamine or Donepezil hypersensibility
- Patient living alone and in a medicalized structure
- Concomitant medication
- Chronical diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galantamine and Donepezilthe 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 | Drug | Galantamine |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dubray Claude, Pr principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Galantamine and Donepezil in people with Alzheimer's Disease, run by University Hospital, Clermont-Ferrand at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.