Skip to main content
Delfa

← Trials/Trial dossier/NCT00679627

TerminatedPhase 3Results posted

A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease

A Randomized, Double-Blind, Placebo-controlled Trial of Long-term (2-year) Treatment of Galantamine in Mild to Moderately-Severe Alzheimer's Disease

Asset

Galantamine

Listed sites

95

Recruiting sites

-

Enrollment

2,051

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoints

•Mini-Mental State Examination (MMSE)•Number of Deaths Reported

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 IDCR012463
Secondary IDGALALZ3005Janssen Research & Development, LLC
NCT IDNCT00679627

Timeline

Milestones

Study first posted2008-05-19estimated
Study start2008-06 (month precision)
Primary completion2012-04actual (month precision)
Study completion2012-05actual (month precision)
Results first posted2013-09-02estimated
Last update posted2013-09-19estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age45 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Outpatients
•diagnosed with mild to moderately-severe, probable or possible AD, established in accordance with the criteria defined by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease Related Disorders Association or the Diagnostic and Statistical Manual, Fourth Edition
•living with or have regular and frequent visits from a responsible caregiver

Exclusion criteria

•Neurodegenerative disorders other than AD, such as Parkinson's Disease, Frontotemporal Dementia or Huntington's disease
•Any of specified conditions which may contribute to dementia
•any of specified coexisting diseases, including significant cardiovascular disease.

Endpoints (18)

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

Global cognition
6
Function / daily living
4
Caregiver / quality of life
4
Safety / tolerability / PK
2
Other (unclassified)
2

Global cognition

6 endpoints
Primary/protocol endpoint

Change From Baseline in the Mini-Mental State Examination (MMSE) Score

Time frame:Baseline, Month 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/registry result

Change From Baseline in the Mini-Mental State Examination (MMSE) Score

Time frame:Baseline, Month 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (mean), Scores on scaleStandard deviation
Placebon=906 Participants-2.144.340
Galantaminen=906 Participants-1.414.050
p<0.001ANCOVA
Secondary/protocol endpoint

Change From Baseline in the Mini-Mental State Examination (MMSE) Score

Time frame:Baseline, Month 6

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)

Time frame:Baseline, Month 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Mini-Mental State Examination (MMSE) Score

Time frame:Baseline, Month 6

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (mean), Scores on scaleStandard deviation
Placebon=906 Participants-0.282.938
Galantaminen=906 Participants0.152.725
p<0.001ANCOVA
Secondary/registry result

Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)

Time frame:Baseline, Month 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (mean), Scores on scaleStandard deviation
PlaceboOrientationn=906 Participants-0.962.320
Registrationn=906 Participants-0.200.771
Attention and Calculationn=906 Participants-0.461.526
Recalln=906 Participants0.001.013
Languagen=906 Participants-0.931.895
GalantamineOrientationn=906 Participants-0.762.128
Registrationn=906 Participants-0.160.692
Attention and Calculationn=906 Participants-0.161.561
Recalln=906 Participants0.101.070
Languagen=906 Participants-0.681.867
p0.194ANCOVA
p0.353ANCOVA
p0.009ANCOVA
p0.158ANCOVA
p0.088ANCOVA

Function / daily living

4 endpoints
Secondary/protocol endpoint

Change From Baseline in Disability Assessment in Dementia (DAD) Scores

Time frame:Baseline, Month 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)

Time frame:Baseline, Month 24

change from baseline, improvement

Secondary/registry result

Change From Baseline in Disability Assessment in Dementia (DAD) Scores

Time frame:Baseline, Month 24

change from baseline, improvement

Posted result

GroupValue (mean), Scores on scaleStandard deviation
Placebon=906 Participants-10.8118.268
Galantaminen=906 Participants-8.1617.251
p0.002ANCOVA
Secondary/registry result

Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)

Time frame:Baseline, Month 24

change from baseline, improvement

Posted result

GroupValue (mean), Scores on scaleStandard deviation
PlaceboInitiationn=906 Participants-13.5322.993
Planning and Organizationn=906 Participants-13.1424.565
Effective Performancen=906 Participants-13.8221.975
Basicn=906 Participants-14.2424.093
Instrumentaln=906 Participants-13.5223.210
Leisuren=906 Participants-13.0235.370
GalantamineInitiationn=906 Participants-9.6020.660
Planning and Organizationn=906 Participants-9.9623.154
Effective Performancen=906 Participants-10.8219.959
Basicn=906 Participants-9.8421.899
Instrumentaln=906 Participants-10.7221.714
Leisuren=906 Participants-10.4632.769
p0.010ANCOVA
p0.043ANCOVA
p0.018ANCOVA
p0.005ANCOVA
p0.054ANCOVA
p0.137ANCOVA

Caregiver / quality of life

4 endpoints
Secondary/protocol endpoint

Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)

Time frame:Baseline, Months 12 and 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)

Time frame:Baseline, Months 12 and 24

change from baseline, improvement

Secondary/registry result

Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)

Time frame:Baseline, Months 12 and 24

change from baseline, improvement

Posted result

GroupValue (number), Percentage of participantsReported bounds
PlaceboHome with friend or relative - Baselinen=906 Participants62.1-
Home with friend or relative - Month 12n=906 Participants61.4-
Home with friend or relative - Month 24n=906 Participants55.3-
GalantamineHome with friend or relative - Baselinen=906 Participants62.8-
Home with friend or relative - Month 12n=906 Participants61.8-
Home with friend or relative - Month 24n=906 Participants60.1-
Secondary/registry result

Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)

Time frame:Baseline, Months 12 and 24

change from baseline, improvement

Posted result

GroupValue (mean), DaysStandard deviation
PlaceboProvided caregiving during past week - Baselinen=906 Participants5.912.094
Provided caregiving during past week - Month 12n=906 Participants6.061.964
Provided caregiving during past week - Month 24n=906 Participants6.131.952
GalantamineProvided caregiving during past week - Baselinen=906 Participants5.772.241
Provided caregiving during past week - Month 12n=906 Participants6.071.969
Provided caregiving during past week - Month 24n=906 Participants6.201.830

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

The Number of Deaths Reported in Participants

Time frame:Up to 2 years

event count, event

Primary/registry result

The Number of Deaths Reported in Participants

Time frame:Up to 2 years

event count, event

Posted result

GroupValue (number), Number of ParticipantsReported bounds
Placebon=1021 Participants56-
Galantaminen=1024 Participants33-
Hazard Ratio (HR)0.5895% CI0.37 - 0.89p0.011Regression, Cox

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change From Baseline in Institutional Status

Time frame:Baseline, Month 24

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline in Institutional Status

Time frame:Baseline, Month 24

change from baseline, improvement

Posted result

GroupValue (number), Number of ParticipantsReported bounds
PlaceboBaselinen=906 Participants1-
Month 24n=906 Participants5-
GalantamineBaselinen=906 Participants0-
Month 24n=906 Participants6-
p0.269Cochran-Mantel-Haenszel
p0.835Cochran-Mantel-Haenszel

Publications (3)

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 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.