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Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range 5-18.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memantine (once daily) | Experimental | Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally |
|
| Memantine (twice daily) | Experimental | Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine (once daily) | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of patients who reported adverse events | baseline to week 16 (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| ADCS - CGIC Score at Week 12 | The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) is a semi-structured interview designed to assess clinically relevant changes in patients with Alzheimer's disease. Items in the ADCS-CGIC interview provide general information, and information about cognition, behaviour, social and daily functioning. Responses to ADCS-CGIC interview result in a global clinical judgement of severity (at baseline) and clinically relevant change at subsequent visits. Severity rated at baseline is only used for reference. The severity at baseline is rated on a 7-point Likert-type scale from 1(normal, not ill at all) to 7 (among the most extremely ill patients). The ADCS-CGIC relevant change is rated on a 7-point Likert-type scale from 1 (marked improvement) to 7 (marked worsening). |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CN001 | Beijing | China | ||||
| CN006 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Memantine (Once Daily) | Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally |
| FG001 | Memantine (Twice Daily) | Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Memantine (Once Daily) | Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally |
| BG001 | Memantine (Twice Daily) | 10 mg given twice daily, tablets, orally AND Placebo tablets twice daily, orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Adverse Events | Number of patients who reported adverse events | All patients treated | Posted | Count of Participants | Participants | baseline to week 16 (end of study) |
|
Baseline to week 16 (end of study)
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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 | Memantine (Once Daily) | Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck | H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Memantine (twice daily) |
| Drug |
|
|
| ADCS - CGIC score at Week 12 |
| Fujian |
| China |
| CN004 | Shandong | China |
| CN002 | Tianjin | China |
| CN007 | Xi'an | China |
| CN003 | Zhejiang | China |
| Administrative reason(s) |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| MMSE Total Score | An 11-item test to assess cognitive aspects of mental function. Subtests assess orientation (item time, place), memory (item registration, recall), attention (item calculation), language (item naming assesses ability of naming, item repetition and comprehension assess the following of verbal commands, item reading assesses understanding of written commands, item writing assessed by writing a sentence spontaneously), and visual construction (item drawing). Scores are dichotomous for each item (1=correct response, 0=incorrect response). Total score=0-30; higher scores indicate lower deficit. | Mean | Standard Deviation | units on a scale |
|
| Modified Hachinski Ischemia Total Score | Hachinski Ischaemic Score is a tool helpful in the bedside differentiation of the commonest dementia types, dementia of Alzheimer's type (DAT) and vascular dementia (VaD). A cut-off score ≤4 for DAT and ≥7 for VaD has a sensitivity of 89% and a specificity of 89%(Moroney 1997). Modified Hachinski Ischemic Scale helps to differentiate between Alzheimer's type and multi-infarct dementia.Score can be 0 - 12. Lower score is more typical of a patient with Alzheimer's disease. Higher score is more typical for multi-infarct dementia. | Mean | Standard Deviation | units on a scale |
|
| Duration of Alzheimer's Disease | Mean | Standard Deviation | years |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | ADCS - CGIC Score at Week 12 | The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) is a semi-structured interview designed to assess clinically relevant changes in patients with Alzheimer's disease. Items in the ADCS-CGIC interview provide general information, and information about cognition, behaviour, social and daily functioning. Responses to ADCS-CGIC interview result in a global clinical judgement of severity (at baseline) and clinically relevant change at subsequent visits. Severity rated at baseline is only used for reference. The severity at baseline is rated on a 7-point Likert-type scale from 1(normal, not ill at all) to 7 (among the most extremely ill patients). The ADCS-CGIC relevant change is rated on a 7-point Likert-type scale from 1 (marked improvement) to 7 (marked worsening). | Full analysis set - all randomised patients who took at least one dose of investigational medicinal product, and who had a valid baseline assessment and at least one valid post-baseline assessment of the ADCS-CGIC. | Posted | Mean | Standard Error | units on a scale | ADCS - CGIC score at Week 12 |
|
|
|
|
| 0 |
| 30 |
| 6 |
| 30 |
| EG001 | Memantine (Twice Daily) | Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally | 1 | 32 | 2 | 32 |
| Sinus bradycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |