Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GAL-JPN-5 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease.
This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient know the name of the study medication), placebo-controlled, parallel-group study to evaluate the efficacy and safety of two fixed doses of galantamine (16 and 24 milligrams per day [mg/day]) in patients with Alzheimer's disease. The study consists of a 4-week screening period during which all patients will receive placebo, and a 24-week double-blind treatment period during which patients will receive placebo, galantamine 16 mg/day, or galantamine 24 mg/day. For patients receiving galantamine treatment, the starting dose is 8 mg/day and increases at 4-week intervals in increments of 8 mg/day. The primary measures of effectiveness are the change from baseline to the end of the study (week 24) in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J). Safety assessments include the incidence of adverse events, clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examination findings. The study hypothesis is that galantamine will be effective in the treatment of Alzheimer's disease. Study drug taken orally twice a day.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Galantamine 16 mg/day | Experimental |
| |
| Galantamine 24 mg/day | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Form= tablet, route= oral use. Corresponding placebo tablets confirmed to be indistinguishable from the galantamine tablets will be administered for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog) | ADAS-J cog is the Japanese version of the cognitive function subscale of the Alzheimer's disease assessment scale (ADAS). This scale is used to detect changes in cognitive function in individuals with Alzheimer disease on the basis of three domains: memory, language and behavior. The minimum score is zero (0) and means well cognitive function. The maximum total score is 70 points, and the larger the score, the more severe the degree of impairment. | Baseline and 24 weeks |
| Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J) | CIBIC plus-J is the Japanese version of the Clinician's Interview-based Impression of Change plus the caregiver's input (CIBIC plus). It is a seven-point categorical assessment scale for evaluating the efficacy of antidementia drugs, ranging from "markedly improved" to "markedly worse". | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Disability Assessment for Dementia (DAD) | Each of the 40 item of the DAD is scored as 1 point= Yes, 0 point= No, or non applicable= N/A. A total score (minimum=0; maximum=40) is the sum of points for each questions converted out 100. Items rated as Not Applicable (N/A) are not considered for the total score. The final score is a percentage that gives an appreciation of global function in activity of daily life (ADL). Higher scores represent less disability in ADL while lower scores indicate more dysfunction. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39498781 | Derived | 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. |
| Label | URL |
|---|---|
| An Efficacy and Safety Study of Galantamine for the Treatment of Patients with Alzheimer's Disease. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group | |
| FG001 | Galantamine Group 1 | Galantamine 16 mg/day |
| FG002 | Galantamine Group 2 | Galantamine 24 mg/day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group | |
| BG001 | Galantamine Group 1 | Galantamine 16 mg/day |
| BG002 | Galantamine Group 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Six participants were excluded from the randomized patients as no evaluation on both ADAS and CIBIC was made after treatment with study medication. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog) | ADAS-J cog is the Japanese version of the cognitive function subscale of the Alzheimer's disease assessment scale (ADAS). This scale is used to detect changes in cognitive function in individuals with Alzheimer disease on the basis of three domains: memory, language and behavior. The minimum score is zero (0) and means well cognitive function. The maximum total score is 70 points, and the larger the score, the more severe the degree of impairment. | Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point. | Posted | Mar 2012 | Mean | Standard Deviation | Scores on a scale | Baseline and 24 weeks |
|
Approximately 28 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA/J V11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA/J V11.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director | Janssen Pharm KK Japan | 81-3-4411-5717 |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
Not provided
Not provided
| ID | Term |
|---|---|
| D005702 | Galantamine |
| ID | Term |
|---|---|
| D047151 | Amaryllidaceae Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Galantamine 16 mg/day | Drug | Type= exact number, number= 8, 16, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, and 16 mg galantamine daily for the remaining 20 weeks. |
|
| Galantamine 24 mg/day | Drug | Type= exact number, number= 8, 16, 24, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, then 16 mg galantamine daily for the following 4 weeks, and 24 mg galantamine daily for the remaining 16 weeks. |
|
| Baseline and 24 weeks |
| Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) | Behave-AD is a CIBIC plus-J subscale that rates the patient's severity of psychotic symptoms. This four-point scale varies from 0 (=none) to 3 (= serious). | Baseline and 24 weeks |
| Change From Baseline in the Mental Function Impairment Scale (MENFIS) | MENFIS is a Clinician's Interview-Based Impression of Change (CIBIC) plus-Japan subscale that rates the patient's severity for mental function impairment. This seven-point scale varies from 0 (= absolutely no impairment) to 6 (=complete impairment). | Baseline and 24 weeks |
| Inappropriate as a subject |
|
| Change of patients for CIBIC plus-J |
|
| Missing or change of caregiver |
|
| Non-compliance |
|
| Other |
|
Galantamine 24 mg/day |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Six participants were excluded from the randomized patients as no evaluation on both Alzheimer's disease assessment scale (ADAS) and Clinician's Interview-Based Impression of Change (CIBIC) was made after treatment with study medication. | Count of Participants | Participants |
|
Galantamine 16 mg/day |
| OG002 | Galantamine Group 2 | Galantamine 24 mg/day |
|
|
|
| Primary | Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J) | CIBIC plus-J is the Japanese version of the Clinician's Interview-based Impression of Change plus the caregiver's input (CIBIC plus). It is a seven-point categorical assessment scale for evaluating the efficacy of antidementia drugs, ranging from "markedly improved" to "markedly worse". | Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point. | Posted | Mar 2012 | Number | patients | 24 weeks |
|
|
|
| Secondary | Change From Baseline in the Disability Assessment for Dementia (DAD) | Each of the 40 item of the DAD is scored as 1 point= Yes, 0 point= No, or non applicable= N/A. A total score (minimum=0; maximum=40) is the sum of points for each questions converted out 100. Items rated as Not Applicable (N/A) are not considered for the total score. The final score is a percentage that gives an appreciation of global function in activity of daily life (ADL). Higher scores represent less disability in ADL while lower scores indicate more dysfunction. | Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point. | Posted | Mar 2012 | Mean | Standard Deviation | Scores on a scale | Baseline and 24 weeks |
|
|
|
|
| Secondary | Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) | Behave-AD is a CIBIC plus-J subscale that rates the patient's severity of psychotic symptoms. This four-point scale varies from 0 (=none) to 3 (= serious). | Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point. | Posted | Mar 2012 | Mean | Standard Deviation | Scores on a scale | Baseline and 24 weeks |
|
|
|
|
| Secondary | Change From Baseline in the Mental Function Impairment Scale (MENFIS) | MENFIS is a Clinician's Interview-Based Impression of Change (CIBIC) plus-Japan subscale that rates the patient's severity for mental function impairment. This seven-point scale varies from 0 (= absolutely no impairment) to 6 (=complete impairment). | Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point. | Posted | Mar 2012 | Mean | Standard Deviation | Scores on a scale | Baseline and 24 weeks |
|
|
|
|
| 13 |
| 194 |
| 146 |
| 194 |
| EG001 | Galantamine Group 1 | Galantamine 16 mg/day | 7 | 192 | 154 | 192 |
| EG002 | Galantamine Group 2 | Galantamine 24 mg/day | 8 | 194 | 163 | 194 |
| Nausea | Gastrointestinal disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Gastric adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Anemia folate deficiency | Blood and lymphatic system disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Post-traumatic headache | Nervous system disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Respiration failure | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA/J V11.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA/J V11.0 | Non-systematic Assessment |
|
The disclosure restriction on PI is that the sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the sponsor requires.
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Moderately worse |
|
| Markedly worse |
|
| Mean Difference (Final Values) |
| 0.5 |
| 2-Sided |
| 95 |
| -1.5 |
| 2.4 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -0.1 |
| 2-Sided |
| 95 |
| -0.8 |
| 0.6 |
| No |
| Superiority or Other |
| Mean Difference (Final Values) |
| -0.3 |
| 2-Sided |
| 95 |
| -1.3 |
| 0.8 |
| No |
| Superiority or Other |