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CompletedPhase 4

A Study of the Effects on Sleep, Attention, and Gastrointestinal Tolerance of Galantamine and Donepezil in Patients With Alzheimer's Disease

A Double-blind, Randomized Pilot Study to Evaluate the Effects of Galantamine and Donepezil on Sleep and Attention and Gastrointestinal (GI) Tolerance in Patients With Mild to Moderate Alzheimer's Disease (AD)

Asset

Galantamine

Listed sites

0

Recruiting sites

-

Enrollment

63

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-24

Primary endpoint

•Differences between galantamine and donepazil for sleep and attention

Identifiers

Registered as

Org study IDCR002002
NCT IDNCT00035204

Timeline

Milestones

Study first posted2002-05-03estimated
Study completion2003-05actual (month precision)
Last update posted2011-06-08estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or post-menopausal female out-patients diagnosed with Alzheimer's disease
•Patients should have mild to moderate dementia as evidenced by a Mini-Mental State Examination score of 10-24 inclusive at screening
•The patient must show a history of cognitive decline that has been gradual in onset and progressive over a period of at least six months
•There must be evidence of sustained memory deterioration in an otherwise alert patient, plus additional impairment in at least one of the following five areas: orientation, judgement and problem solving, functioning in community affairs, functioning in home and hobbies, or functioning in personal care
•The caregiver resides with the patient and is able to speak with the investigative team about the patient's activities, medication use and adverse events. In addition, the caregiver will participate in assessment interviews and complete questionnaires for themselves and the patients. The caregiver will monitor their own sleep, the patient's sleep, and complete questionnaires regarding sleep patterns and care giving activities

Exclusion criteria

•Neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease
•One of the following conditions possibly resulting in cognitive impairment: acute cerebral trauma or injuries secondary to chronic trauma, hypoxic cerebral damage, e.g., post resuscitation (cardiac arrest, post anesthesia, secondary to severe self-poisoning episode, or secondary to severe hypovolemia)
•Patients with the following medical conditions: any history of epilepsy or convulsions except for febrile convulsions during childhood, clinically significant: endocrine disease, metabolic disease, psychiatric disease, cardiovascular disease, peptic ulcer disease, hepatic disease, renal disease, pulmonary disturbances or urinary outflow obstruction
•Use of any agent for the treatment of dementia (approved, experimental or over the counter agents) including patients who have previously received tacrin, donepazil, metrifonate, rivastigmine tartrate, galantamine, or memantine for treatment of Alzheimer's disease

Endpoints (2)

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

Executive function / language
1
Caregiver / quality of life
1

Executive function / language

1 endpoint
Primary/protocol endpoint

To measure the differences between galantamine and donepazil for sleep and attention, explore methods of measuring sleep in patients with Alzheimer's Disease (AD)and their caregivers and attention in AD patients; GI tolerance

descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

To assess the tolerability, overall effect, quality of life and safety of galantamine compared with donepezil

descriptive

Publications (1)

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.