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CompletedPhase 3

Safety and Efficacy of High Dose, Rapid Titration Galantamine in Patients With Alzheimer's Disease

A European Multi-Center Study to Determine the Safety and Efficacy of Galanthamine Hydrobromide 40mg/Day (32 mg /Day GAL Base, Tid Dose Regimen) in Patients Diagnosed With Alzheimer-Type Dementia

Asset

Galantamine

Listed sites

0

Recruiting sites

-

Enrollment

554

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

Identifiers

Registered as

Org study IDCR005884
NCT IDNCT00338117

Timeline

Milestones

Study start1995-08 (month precision)
Study completion1997-05actual (month precision)
Study first posted2006-06-20estimated
Last update posted2010-04-28estimated

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

•Have been meeting the diagnostic criteria of Alzheimer's disease
•mild or moderate dementia as measured by the Mini Mental State Examination (MMSE) score
•live with or have daily visits from a responsible caregiver

Exclusion criteria

•Parkinson's disease
•Pick's disease
•secondary or pseudodementias
•currently diagnosed epilepsy
•history of endocrine disorder
•significant heart disease
•drug or alcohol abuse
•kidney or liver dysfunction
•women of child-bearing potential unless appropriate birth-control method is used
•sensitivity to the study drug.

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.

Global cognition

2 endpoints
Primary/protocol endpoint

The primary outcomes included evaluations by EURO-ADAS cognitive score, CIBIC Plus, and NOSGER at 6 months.

ADAS-Cog

descriptive

Secondary/protocol endpoint

EURO-ADAS non-cognitive score; MMSE; Short Cognitive Performance Test (SKT) sub-set 6; Neuropsychological Assessment Battery (NAB); incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-lead ECG.

Mini-Mental State Examination (MMSE)

event count, event

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.