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ACHALZSLEEP

CompletedPhase 4

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

Lead sponsor

Associacao Fundo de Incentivo a Psicofarmcologia

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Polysomnography parameters

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCEP nº051/99

NCT IDNCT00480870

Timeline

Milestones

Study start1999-04 (month precision)

Study completion2005-01actual (month precision)

Study first posted2007-05-31estimated

Last update posted2007-12-04estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•Other causes of dementia

•Other severe medical or psychiatric disease

•Clinical indication of psychoactive drugs other than experimental drug

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Other (unclassified)

Fluid / digital biomarkers

Behavior / neuropsychiatric

Neuroimaging

Global cognition

3 endpoints

Secondary/protocol endpoint

Mini-mental state examination

Time frame:onset

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

ADAS-cog scores

Time frame:onset, 3 and 6 months of treatment

ADAS-Cog

descriptive

Secondary/protocol endpoint

Clinical Dementia Rating

Time frame:onset

descriptive

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

Polysomnography parameters: sleep structure, respiratory, limb movements

Time frame:onset, 3 and 6 months of treatment

descriptive

Neuroimaging

1 endpoint

Secondary/protocol endpoint

Brain magnetic resonance imaging

Time frame:onset

descriptive

Fluid / digital biomarkers

2 endpoints

Secondary/protocol endpoint

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).

Time frame:onset, 3 and 6 months of treatment

event count, event

Secondary/protocol endpoint

EEG slowing ratio

Time frame:onset, 3 and 6 monthes of treatment

ratio, descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

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

Time frame:onset

descriptive

Secondary/protocol endpoint/low confidence

electroencephalogram

Time frame:onset

descriptive

Secondary/protocol endpoint/low confidence

IDATE

Time frame:onset

descriptive

Publications (5)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.