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This study will test the use of venlafaxine to treat the depression in Alzheimer's Disease. Venlafaxine works by increasing natural substances in the brain (serotonin and norepinephrine) that help maintain mental balance. Alzheimer's disease (AD) is the commonest neurodegenerative disease of aging and the cause of major financial and emotional burden to patients, families and caregivers, and society. Depression is a very common symptom of AD, affecting as many as 50% of patients over their illness. Depression in AD (Alzheimer's disease) contributes greatly to patient disability and caregiver distress. Neither psychosocial interventions nor psychotropic medications have proven effective to date for the treatment of depression in AD.Venlafaxine is approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depression but it is not known whether or not it can help depression in Alzheimer's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venlafaxine | Active Comparator | 225 mg daily over 12 weeks |
|
| Sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Capsule matching active drug to be taken once a day for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Dose Response Using the Modified Alzheimer's Disease (AD) Cooperative Study-Clinical Global Impression of Change. | Treatment will be considered efficacious if the proportion of worse categories (including 'minimal worsening', 'moderate worsening', or 'marked worsening') is lower under treatment than control on the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. Clinical Global Impression of Change: This is a 7-item score ranging from "markedly worse" to "markedly improved". It is assessed by the study clinician who interviews both participant and informant and makes an informed judgment how to incorporate their input | 12 weeks |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins at Bayview | Baltimore | Maryland | 21225 | United States | ||
| Reading Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Venlafaxine | 225 mg daily over 12 weeks Venlafaxine: 225 mg daily for 12 weeks |
| FG001 | Sugar Pill | Placebo: Capsule matching active drug to be taken once a day for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Venlafaxine | 225 mg daily over 12 weeks Venlafaxine: 225 mg daily for 12 weeks |
| BG001 | Sugar Pill | Placebo: Capsule matching active drug to be taken once a day for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Changes in Dose Response Using the Modified Alzheimer's Disease (AD) Cooperative Study-Clinical Global Impression of Change. | Treatment will be considered efficacious if the proportion of worse categories (including 'minimal worsening', 'moderate worsening', or 'marked worsening') is lower under treatment than control on the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. Clinical Global Impression of Change: This is a 7-item score ranging from "markedly worse" to "markedly improved". It is assessed by the study clinician who interviews both participant and informant and makes an informed judgment how to incorporate their input | Posted | Count of Participants | Participants | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Venlafaxine | 225 mg daily over 12 weeks Venlafaxine: 225 mg daily for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Rosenberg, MD | Johns Hopkins University | 410-550-9883 | prosenb9@jhmi.edu |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Venlafaxine |
| Drug |
225 mg daily for 12 weeks |
|
| West Reading |
| Pennsylvania |
| 19611 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Sugar Pill |
Placebo: Capsule matching active drug to be taken once a day for 12 weeks |
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 1 |
| 3 |
| EG001 | Sugar Pill | Placebo: Capsule matching active drug to be taken once a day for 12 weeks | 0 | 2 | 0 | 2 | 1 | 2 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Low potassium | Cardiac disorders | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |