AzTrials
AzTrials

Alzheimer DiseasePhase 4ACHALZSLEEPNCT00480870

The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients

A Phase 4 study testing donepezil in people with Alzheimer Disease and Sleep Apnea, Obstructive, run by Associacao Fundo de Incentivo a Psicofarmcologia at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the effects of the anticholinesterase drug donepezil on sleep in Alzheimer disease patients. Sleep structure and respiratory parameters will be analyzed by polysomnography. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer Disease, Sleep Apnea, Obstructive
What is being tested?
donepezil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
1 siteBrazil
Study dates
Apr 1999to Jan 2005
Phase
Phase 4
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 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Alzheimer's disease based on the probability criteria of the Alzheimer's Disease and Related Disorders Association
  • Rated 1 and 2 (mild to moderate level) on the Brazilian version of the Clinical Dementia Rating

Who cannot join

  • Other causes of dementia
  • Other severe medical or psychiatric disease
  • Clinical indication of psychoactive drugs other than experimental drug

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto do Sono

    São Paulo, São Paulo, 04020-060

Other trials in Brazil

About this study

The purpose of this study is to determine the effects of the anticholinesterase drug donepezil on sleep in Alzheimer disease patients. Sleep structure and respiratory parameters will be analyzed by polysomnography.

Read the detailed description

Central acting cholinesterase inhibitors are the first primary pharmacological treatment approved for Alzheimer disease, of which donepezil is the most frequently used. Multicenter studies have found little toxicity, and its side effects (diarrhea, nausea, vomiting, nightmares, among others) are mild and transient. According to the literature, cholinergic active drugs may be expected to affect REM (rapid eye movement) sleep. Another possible effect is related to respiratory parameters in patients with Alzheimer disease and obstructive sleep apnea. In fact, cholinergic activity influences the upper airway opening via central and peripheral mechanisms.

Intervention: Patients will be administered donepezil or placebo. The study has a randomized, double-blind placebo-controlled design. Complete polysomnography with REM sleep EEG spectral analysis and ADAS-cog scoring will be performed at baseline and after 3 and 6 months.

Being tested
donepezil, Placebo
Keywords
Alzheimer, polysomnography, REM sleep, donepezil, sleep apnea, oxygen saturation
Medical subject headings
Alzheimer Disease, Sleep Apnea, Obstructive, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • donepezilDrug

    donepezil 5 mg 1 p / day for 1 month and 2p / day for 5 months on.

  • PlaceboDrug

    Placebo 1p / day for 1 month and 2 / day for 5 months on

Study groups in NCT00480870
Study groupRoleWhat they receive
AExperimentalDonepezil treated Alzheimer patients
Receives: Drug: donepezil
BPlacebo comparatorPlacebo treated Alzheimer patients
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Polysomnography parameters: sleep structure, respiratory, limb movements

    Measured: onset, 3 and 6 months of treatment

Secondary outcomes (9)

  1. Brain magnetic resonance imaging

    Measured: onset

  2. laboratory tests: hematological evaluation, creatinine, vitamin B12-folic acid, thyroid hormones, GOT, GPT, GGT, bilirubin, fasting glycemia, venereal disease research test and urine sediment

    Measured: onset

  3. electroencephalogram

    Measured: onset

  4. Mini-mental state examination

    Measured: onset

  5. IDATE

    Measured: onset

  6. Frequency bands of scalp EEG areas: overall (average of all electrodes), frontal (F3, F4, F7, F8, Fz), temporal (T3, T4, T5, T6), parietal (P3, P4, Pz), central (C3, C4, Cz), and occipital (O1, O2, Oz).

    Measured: onset, 3 and 6 months of treatment

  7. ADAS-cog scores

    Measured: onset, 3 and 6 months of treatment

  8. Clinical Dementia Rating

    Measured: onset

  9. EEG slowing ratio

    Measured: onset, 3 and 6 monthes of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2007 (estimated)
  2. Study startApr 1999
  3. Study completionJan 2005

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00480870
Sponsor's protocol ID
CEP nº051/99
Acronym
ACHALZSLEEP
Status last verified
Dec 2007
First submitted
30 May 2007
Last updated
4 Dec 2007
Results posted
No
Data monitoring committee
No

Publications

  • Rosa A, Poyares D, Moraes W, Cintra F. Methodology in clinical sleep research. Cell Mol Life Sci. 2007 May;64(10):1244-53. doi: 10.1007/s00018-007-6535-y.

    PubMed 17364137

  • Lucchesi LM, Pradella-Hallinan M, Lucchesi M, Moraes WA. [Sleep in psychiatric disorders]. Braz J Psychiatry. 2005 May;27 Suppl 1:27-32. doi: 10.1590/s1516-44462005000500006. Epub 2005 Jul 28. Portuguese.

    PubMed 16082452

  • Moraes Wdos S, Poyares DR, Guilleminault C, Ramos LR, Bertolucci PH, Tufik S. The effect of donepezil on sleep and REM sleep EEG in patients with Alzheimer disease: a double-blind placebo-controlled study. Sleep. 2006 Feb;29(2):199-205. doi: 10.1093/sleep/29.2.199.

    PubMed 16494088

  • McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.

    PubMed 33189083

  • Moraes W, Poyares D, Sukys-Claudino L, Guilleminault C, Tufik S. Donepezil improves obstructive sleep apnea in Alzheimer disease: a double-blind, placebo-controlled study. Chest. 2008 Mar;133(3):677-83. doi: 10.1378/chest.07-1446. Epub 2008 Jan 15.

    PubMed 18198262

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing donepezil in people with Alzheimer Disease and Sleep Apnea, Obstructive, run by Associacao Fundo de Incentivo a Psicofarmcologia at 1 site in Brazil.

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 2 inclusion and 3 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 4 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Polysomnography parameters: sleep structure, respiratory, limb movements (time frame: onset, 3 and 6 months of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00480870, which also lists 5 linked publications.

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 4 Dec 2007.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in