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CompletedPhase 3

Evaluation of Galantamine in the Treatment of Alzheimer's Disease

Placebo Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy Under a Slow-Titration Regimen

Lead sponsor

Janssen, LP

Asset

Galantamine

Listed sites

55

Recruiting sites

-

Enrollment

-

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-22•Study partner/caregiver required

Primary endpoint

-

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 IDIA0009
NCT IDNCT00000172

Timeline

Milestones

Study first posted1999-11-01estimated
Last update posted2005-06-24estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age0 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Probable Alzheimer's disease
•Mini-Mental State Examination (MMSE) 10-22 and ADAS greater than or equal to 18
•Alzheimer's Disease Assessment Scale cognitive portion (ADAS-cog-11) score of at least 18
•Opportunity for Activities of Daily Living
•Caregiver
•Subjects who live with or have regular daily visits from a responsible caregiver (visit frequency: preferably daily but at least 5 days/week). This includes a friend or relative or paid personnel. The caregiver should be capable of assisting with the subject's medication, prepared to attend with the subject for assessments, and willing to provide information about the subject

Exclusion criteria

•Conditions that could confound diagnosis
•Neurodegenerative disorders
•Acute cerebral trauma
•Psychiatric disease
•More than one infarct on CT/MRI scans
•History of alcohol or drug abuse
•Contradictions for a cholinominetic agent: seizures; ulcers; pulmonary conditions (including severe asthma); unstable angina; Afib; bradycardia less than 50; and AV block.

Endpoints (0)

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.

No endpoints recorded for this trial.

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.