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CompletedPhase 3

A Cardiac Safety Study of Galantamine in the Treatment of Alzheimer's Disease.

Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: A Cardiac Safety Study.

Asset

Galantamine

Listed sites

0

Recruiting sites

-

Enrollment

139

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 11-24•Study partner/caregiver required

Primary endpoint

•Hourly mean heart rates and PR intervals during each of the 24-hour Holter

Identifiers

Registered as

Org study IDCR012118
NCT IDNCT00309725

Timeline

Milestones

Study completion1999-10actual (month precision)
Study first posted2006-04-03estimated
Last update posted2011-05-18estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Outpatients diagnosed with Alzheimer's disease in accordance with NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) classification for probable Alzheimer's disease
•Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 11 to 24, inclusive, at baseline
•History of cognitive decline that has been gradual in onset and progressive over a period of at least 6 months
•Evidence of sustained memory deterioration in an otherwise alert patient, plus additional impairment in at least one of these five areas: orientation, judgment and problem-solving, functioning in community affairs, functioning in home and hobbies, and functioning in personal care
•Patients who live with or have regular daily visits from one or more responsible caregiver who are capable of assisting with the patient's medication, able to accompany the patient for assessments, and willing to provide information about the patient.On days that the patient was sent home with a Holter monitor, the caregiver was required to stay with the patient in the same household for the 24 hour duration of the cardiac assessment to ensure that the monitor lead placement remained intact. The caregiver was to be available the following day for the return of the Holter monitoring device
•Patient or patient's relative, guardian or legal representative have signed the informed consent

Exclusion criteria

•Disorders such as Parkinson's disease, Pick's disease, or Huntington's chorea, Down's syndrome, Creutzfeldt-Jakob disease, Cushing's syndrome, or uncontrolled diabetes
•Cognitive impairment resulting from trauma, injury, or hypoxia
•Infection
•Mental retardation or dementia or clinically active cerebrovascular disease
•Current, clinically significant cardiovascular disease that would limit the patient's ability to complete a six-week trial.

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

Safety / tolerability / PK
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Pharmacokinetics and other safety parameters including ECG parameters were other parameters of interest.

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Hourly mean heart rates and PR intervals during each of the 24-hour Holter monitoring periods; Twenty-four hour mean, minimum and maximum heart rates and PR intervals during each of the 24-hour Holter monitoring periods

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.