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CompletedPhase 3

Long-term Safety and Efficacy of Galantamine in Alzheimer's Disease

Long Term Safety and Efficacy of Galantamine in Alzheimer's Disease (Extension INT-8)

Asset

Galantamine

Listed sites

0

Recruiting sites

-

Enrollment

241

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥45

Primary endpoint

•Primary outcome is safety

Identifiers

Registered as

Org study IDCR012070
NCT IDNCT00304629

Timeline

Milestones

Study start2000-03 (month precision)
Study completion2002-03actual (month precision)
Study first posted2006-03-20estimated
Last update posted2011-02-01estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age45 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Patients must have taken trial medication during the 24-month trial period of GAL-INT-8 and should be enrolled within 1 month after completion
•Patients and their primary caregiver give informed consent for the participation in the trial
•Patients must have remained in good health, as determined by medical history, complete physical examination and laboratory tests

Exclusion criteria

•If a patient developed, during the trial GAL-INT-8, symptoms of other neurological or psychiatric diseases that might contribute to dementia, the subject cannot be enrolled. This includes subjects developing neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, or Creutzfeldt-Jacob disease, and subjects with cognitive impairment resulting from stroke, acute cerebral trauma, hypoxic cerebral damage, infection or primary or metastatic cerebral neoplasia
•Subjects with the following co-existing medical conditions:
a)Any history of epilepsy or convulsions except for febrile convulsions during childhood
b)Peptic ulcer: if the ulcer is considered to be still "active", i.e., if treatment for this condition started <3 months ago or if treatment is not successful (symptoms still present), the subject is not eligible.
c)Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances
•Patients with current, clinically significant cardiovascular disease that would be expected to limit the subject's ability to complete a 12-month trial. The following would usually be considered clinically significant cardiovascular disease: a) Unstable angina
•angina or coronary artery disease that required a change in medication (anti-angina or digitalis) within the last 3 months
b)Decompensated congestive heart failure i.e. when symptoms occur in a subject on stable medication during rest or light exercise (NYHA III and IV). Note: if the only signs of decompensation are pretibial or malleolar oedema and the exercise tolerance is still reasonable (absence of dyspnoea) the subject should not be excluded
c)Cardiac disease potentially resulting in syncope, near syncope or other alterations of mental status
•In addition, the following conditions should lead to exclusion: atrial fibrillation without prophylactic treatment to prevent thromboembolic stroke, bradycardia <50 beats/min., atrioventricular block > first degree.
d)Severe mitral or aortic valvular disease
e)Hypotension or treatment for hypotension
f)Systolic blood pressure greater than 170 mmHg or diastolic blood pressure greater than 110 mmHg
•Patients using any agent for the treatment of dementia (approved, experimental, including over the counter agents), including, but not limited to nootropic agents, cholinomimetic agents, choline, oestrogens taken without medical need, chronic NSAIDs (30 consecutive days), vitamin E more than 30 IU daily, and deprenyl
•Conditions that could interfere with the absorption of the compound or with the evaluation of the 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

Function / daily living
1
Safety / tolerability / PK
1

Function / daily living

1 endpoint
Secondary/protocol endpoint

The secondary outcome is effectiveness as measured by a cognitive scale (ADAS) and by activities of daily living (DAD).

descriptive

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

The primary outcome is safety as measured by adverse events, laboratory tests, vital signs, weight, physical exam and electrocardiogram

event count, event

Publications (2)

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.