Trial · NCT00679627
A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease
NCT00679627, Phase 3, Terminated, Janssen Research & Development, LLC; results first posted 2013-09-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease. Trials, record NCT00679627. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00679627
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease
- NCT number
- NCT00679627
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,051 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Alzheimer's Disease
- Interventions
- Galantamine, Placebo
- First posted
- 2008-05-19
- Last updated
- 2013-09-19
- Results first posted
- 2013-09-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Mini-Mental State Examination (MMSE) Score | Baseline, Month 24 | The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening. |
| Primary | The Number of Deaths Reported in Participants | Up to 2 years | An external Data Safety Monitoring Board (DSMB) was assigned for this study to monitor the progress of the study and to ensure that the safety of participants was not compromised. |
| Secondary | Change From Baseline in the Mini-Mental State Examination (MMSE) Score | Baseline, Month 6 | The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening. |
| Secondary | Change From Baseline in Disability Assessment in Dementia (DAD) Scores | Baseline, Month 24 | The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities. |
| Secondary | Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Baseline, Months 12 and 24 | The APAS-CarB is a measure used to evaluate participant status and caregiver burden. The table below presents Patient Accommodation assessed as the percentage of participants "home with friend or relative" using the APAS-CarB. |
| Secondary | Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Baseline, Months 12 and 24 | The table below presents the number of days that caregiving activities were provided during the past week. |
| Secondary | Change From Baseline in Institutional Status | Baseline, Month 24 | This table describes the number of participants who were reported as institutionalized at baseline and Month 24. |
| Secondary | Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language) | Baseline, Month 24 | The MMSE, is a validated, brief examination that rates subjects on orientation (total score, 10), registration (total score, 3), attention (total score, 5), calculation (total score, 5), recall (total score, 3), and language (total score, 9). The maximum score is 30 (only the higher of the two scores for attention and calculation \[each with a maximum score of 5\] was used). A higher score compared with baseline indicates less impairment. |
| Secondary | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Baseline, Month 24 | The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Mini-Mental State Examination (MMSE) Score | Baseline, Month 24 | An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure. | Scores on scale | MEAN |
| PRIMARY | The Number of Deaths Reported in Participants | Up to 2 years | The safety analysis was performed on the safety population, ie, all randomized participants who received at least one dose of the study drug. | Number of Participants | NUMBER |
| SECONDARY | Change From Baseline in the Mini-Mental State Examination (MMSE) Score | Baseline, Month 6 | An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure. | Scores on scale | MEAN |
| SECONDARY | Change From Baseline in Disability Assessment in Dementia (DAD) Scores | Baseline, Month 24 | An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline DAD measure. | Scores on scale | MEAN |
| SECONDARY | Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Baseline, Months 12 and 24 | An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline APAS-CarB measure. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Baseline, Months 12 and 24 | The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure. | Days | MEAN |
| SECONDARY | Change From Baseline in Institutional Status | Baseline, Month 24 | The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure. | Number of Participants | NUMBER |
| SECONDARY | Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language) | Baseline, Month 24 | The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure. | Scores on scale | MEAN |
| SECONDARY | Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure) | Baseline, Month 24 | This analysis was performed in the intent-to-treat population which included all randomized participants who had at least 1 postbaseline DAD measure. | Scores on scale | MEAN |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Mini-Mental State Examination (MMSE) Score | Placebo | -2.14 | Standard Deviation 4.340 | Scores on scale | |
| Change From Baseline in the Mini-Mental State Examination (MMSE) Score | Galantamine | -1.41 | Standard Deviation 4.050 | Scores on scale | |
| The Number of Deaths Reported in Participants | Placebo | 56 | Number of Participants | ||
| The Number of Deaths Reported in Participants | Galantamine | 33 | Number of Participants | ||
| Change From Baseline in the Mini-Mental State Examination (MMSE) Score | Placebo | -0.28 | Standard Deviation 2.938 | Scores on scale | |
| Change From Baseline in the Mini-Mental State Examination (MMSE) Score | Galantamine | 0.15 | Standard Deviation 2.725 | Scores on scale | |
| Change From Baseline in Disability Assessment in Dementia (DAD) Scores | Placebo | -10.81 | Standard Deviation 18.268 | Scores on scale | |
| Change From Baseline in Disability Assessment in Dementia (DAD) Scores | Galantamine | -8.16 | Standard Deviation 17.251 | Scores on scale | |
| Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Placebo | Home with friend or relative - Baseline | 62.1 | Percentage of participants | |
| Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB) | Galantamine | Home with friend or relative - Baseline | 62.8 | Percentage of participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 1,021 | |
| Overall Study | STARTED | Galantamine | 1,024 | |
| Overall Study | COMPLETED | Placebo | 322 | |
| Overall Study | COMPLETED | Galantamine | 339 | |
| Overall Study | NOT COMPLETED | Placebo | 699 | |
| Overall Study | NOT COMPLETED | Galantamine | 685 |
Source ClinicalTrials.gov
Adverse events388
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | Placebo | 48 | 1,021 | |
| other | Vertigo | Ear and labyrinth disorders | Galantamine | 57 | 1,024 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 24 | 1,021 | |
| other | Nausea | Gastrointestinal disorders | Galantamine | 85 | 1,024 | |
| other | Headache | Nervous system disorders | Placebo | 58 | 1,021 | |
| other | Headache | Nervous system disorders | Galantamine | 58 | 1,024 | |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 1,021 | |
| serious | Anaemia | Blood and lymphatic system disorders | Galantamine | 0 | 1,024 | |
| serious | Acute Myocardial Infarction | Cardiac disorders | Placebo | 1 | 1,021 | |
| serious | Acute Myocardial Infarction | Cardiac disorders | Galantamine | 1 | 1,024 |
1 to 10 of 388Source ClinicalTrials.gov
See all 388 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Galantamine | ||
| Total, other adverse events | Placebo | 115 | 1,021 |
| Total, other adverse events | Galantamine | 168 | 1,024 |
| Total, serious adverse events | Placebo | 123 | 1,021 |
| Total, serious adverse events | Galantamine | 129 | 1,024 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Galantamine vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT00679627/results?page=2