← Trials/Trial dossier/NCT00814801

CompletedPhase 3Results posted

An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease

Placebo-controlled Confirmatory Study of Galantamine (R113675) for Alzheimer's Type Dementia

Lead sponsor

Janssen Pharmaceutical K.K.

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

580

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-22

Primary endpoints

•The Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)•Distribution of Clinician's Interview-Based Impression of Change Plus - Japan

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 IDCR010297

Secondary IDGAL-JPN-5Janssen Pharmaceutical K.K., Japan

NCT IDNCT00814801

Timeline

Milestones

Study start2007-02 (month precision)

Primary completion2008-09actual (month precision)

Study completion2008-09actual (month precision)

Study first posted2008-12-25estimated

Results first posted2012-07-04estimated

Last update posted2014-04-17estimated

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

•Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria

•Having a Mini-Mental Status Examination (MMSE) score of 10 - 22 inclusive

•Having an Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) score of at least 18

•Exhibiting an onset and progression of cognitive dysfunction during at least 6 months prior to the screening period

Exclusion criteria

•Patients with neurodegenerative diseases other than Alzheimer's disease, such as Lewy bodies disease, (dementia due to tiny round structures made of proteins that develop within nerve cells in the brain), Parkinsonism, etc

•Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc

•Patients with multi-infarct dementia (brought on by a series of strokes) or active cerebrovascular disease

•Patients with clinically significant cardiovascular disease

•Patients currently taking drugs such as a cholinesterase inhibitors, which improve cerebral circulation/metabolism

Endpoints (10)

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

Other clinical outcomes

Global cognition

Function / daily living

Caregiver / quality of life

Global cognition

2 endpoints

Primary/protocol endpoint

Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)

Time frame:Baseline and 24 weeks

change from baseline, improvement

Primary/registry result

Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)

Time frame:Baseline and 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Placebo Groupn=191 Participants	0.90	5.89
Galantamine Group 1n=191 Participants	-0.58	5.87
Galantamine Group 2n=192 Participants	-1.66	5.37

Mean Difference (Final Values)-1.4995% CI-2.64 - -0.34p0.0113Least Square Means

Mean Difference (Final Values)-2.5995% CI-3.74 - -1.44p<0.0001Least Square Means

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline in the Disability Assessment for Dementia (DAD)

Time frame:Baseline and 24 weeks

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Disability Assessment for Dementia (DAD)

Time frame:Baseline and 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Placebo Groupn=191 Participants	-2.8	10.3
Galantamine Group 1n=191 Participants	-1.0	9.4
Galantamine Group 2n=192 Participants	-2.2	9.3

Mean Difference (Final Values)1.895% CI-0.2 - 3.7p0.0774Least Square Means

Mean Difference (Final Values)0.595% CI-1.5 - 2.4p0.6207Least Square Means

Caregiver / quality of life

2 endpoints

Primary/protocol endpoint

Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)

Time frame:24 weeks

descriptive

Primary/registry result

Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)

Time frame:24 weeks

descriptive

Posted result

Group	Value (number), patients	Reported bounds
Placebo GroupMarkedly improvedn=191 Participants	0	-
Moderately improvedn=191 Participants	7	-
Minimally improvedn=191 Participants	36	-
No changen=191 Participants	64	-
Minimally worsen=191 Participants	62	-
Moderately worsen=191 Participants	22	-
Markedly worsen=191 Participants	0	-
Galantamine Group 1Markedly improvedn=191 Participants	0	-
Moderately improvedn=191 Participants	12	-
Minimally improvedn=191 Participants	39	-
No changen=191 Participants	60	-
Minimally worsen=191 Participants	64	-
Moderately worsen=191 Participants	16	-
Markedly worsen=191 Participants	0	-
Galantamine Group 2Markedly improvedn=192 Participants	1	-
Moderately improvedn=192 Participants	4	-
Minimally improvedn=192 Participants	32	-
No changen=192 Participants	73	-
Minimally worsen=192 Participants	61	-
Moderately worsen=192 Participants	20	-
Markedly worsen=192 Participants	1	-

Other clinical outcomes

4 endpoints

Secondary/protocol endpoint

Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)

Time frame:Baseline and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Mental Function Impairment Scale (MENFIS)

Time frame:Baseline and 24 weeks

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)

Time frame:Baseline and 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Placebo Groupn=191 Participants	0.0	3.1
Galantamine Group 1n=191 Participants	-0.2	4.2
Galantamine Group 2n=192 Participants	-0.3	3.1

Mean Difference (Final Values)0.195% CI-0.6 - 0.8p0.8419Least Square Means

Mean Difference (Final Values)-0.195% CI-0.8 - 0.6p0.7942Least Square Means

Secondary/registry result

Change From Baseline in the Mental Function Impairment Scale (MENFIS)

Time frame:Baseline and 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Placebo Groupn=191 Participants	2.2	5.2
Galantamine Group 1n=191 Participants	1.6	5.2
Galantamine Group 2n=192 Participants	1.9	5.2

Mean Difference (Final Values)-0.595% CI-1.6 - 0.5p0.3141Least Square Means

Mean Difference (Final Values)-0.395% CI-1.3 - 0.8p0.6089Least Square Means

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

Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.
PMID39498781via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.