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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004489-41 | EudraCT Number |
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Study terminated due to too slow enrollment
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To investigate the potential to reduce concomitant antipsychotic medication use in subjects with moderate dementia of Alzheimer's type, treated with memantine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memantine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | memantine tablets, twice a day (bid), for 20 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Dose Reduction of Antipsychotics (AP) in Percent of Defined Daily Dose (DDD) From Baseline to a Post-baseline Visit at Which the Value of the Visual Analogue Scale (VAS) Compared With the Baseline Value Was =< 15 Percent. | VAS: see #8. Mean "percent of the total Defined Daily Dose (DDD)", averaged over one week, was calculated. Total DDD was calculated as sum of DDD for each AP drug. DDD is the assumed average maintenance dose per day defined by WHO. The reduction of AP Δ [percent] was calculated as a difference between the mean total DDD recorded at baseline and the mean total DDD recorded at the respective week. Measurements from those post-baseline visits were taken into account only when the value of the VAS was not substantially worse compared to baseline. | Week 8-20 post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20. | See #1 and #8. Change of <0 reveals a reduction of AP compared to baseline. | Week 8-20 post Baseline |
| Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | Merz Pharmaceuticals GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexianer Hospital | Krefeld | North Rhine-Westphalia | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Memantine | Memantine tablets, twice a day (bid). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Memantine | Memantine tablets, twice a day (bid). |
| 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 | Maximum Dose Reduction of Antipsychotics (AP) in Percent of Defined Daily Dose (DDD) From Baseline to a Post-baseline Visit at Which the Value of the Visual Analogue Scale (VAS) Compared With the Baseline Value Was =< 15 Percent. | VAS: see #8. Mean "percent of the total Defined Daily Dose (DDD)", averaged over one week, was calculated. Total DDD was calculated as sum of DDD for each AP drug. DDD is the assumed average maintenance dose per day defined by WHO. The reduction of AP Δ [percent] was calculated as a difference between the mean total DDD recorded at baseline and the mean total DDD recorded at the respective week. Measurements from those post-baseline visits were taken into account only when the value of the VAS was not substantially worse compared to baseline. | Intention to treat (ITT) | Posted | Mean | Standard Deviation | Percent of daily dose [DDD] | Week 8-20 post baseline |
|
All SAEs/AEs from baseline until 4 weeks after end of treatment (in total 20 weeks)
The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.
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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 | Memantine tablets, twice a day (bid). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
Early termination due to too slow enrollment lead to a small sample size, limiting the ability for confirmatory analysis. All analysis of the primary efficacy endpoint were treated as exploratory.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Public Disclosure | Merz Pharmaceuticals GmbH | +49 69 1503 865 | matthias.zerm@merz.de |
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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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MMSE is a brief, physician-administered scale, designed for measuring the cognitive functions, such as: orientation, memory, attention, naming, and comprehension. The scoring range of MMSE is 0 to 30 points. A score of 23 or lower is indicative of cognitive impairment. Change of >0 reveals an improvement compared to baseline. |
| Week 20 post baseline |
| Change of "Test for the Early Detection of Dementia With Discrimination From Depression [TE4D]" Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - First Part: Total Dementia | TE4D is a psychometric, physician-administered test that is used for both screening subjects with early dementia and monitoring the clinical progress of the disease. The first part consists of 9 items, which assess different symptoms associated with dementia such as memory, time-orientation, etc. The scoring range is 0 to 50 points. A score of 35 or lower is an indication of dementia. A change >0 represents an improvement. | Week 4-20 post baseline |
| Change of "Test for the Early Detection of Dementia With Discrimination From Depression [TE4D]" Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - Second Part: Total Depression | TE4D is a psychometric, physician-administered test that is used for both screening subjects with early dementia and monitoring the clinical progress of the disease. The second part consists of a proxy rating and a self-assessment rating. The scoring range of each rating is 1 to 10. The maximum total score of 10 corresponds to severe depression. A change <0 reveals an improvement compared to baseline. | Week 4-20 post Baseline |
| Change of Modified Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADLB19) Score Value From Baseline to Week 4, 8, 12, 16, and/or 20. | The modified ADCS-ADL19 is comprehensive battery of ADL questions aimed to measure the functional ability of subjects with Dementia of Alzheimer's type over a broad range of dementia severity. It has a scoring range of 0 to 54 with the lower scores indicating greater functional impairment. Each ADL item was rated from the highest level of independent performance to complete loss. Change of >0 reveals an improvement compared to baseline. | Week 4-20 post Baseline |
| Change of Nurses' Observation Scale for Geriatric Patients [NOSGER] Total Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 | NOSGER is a comprehensive scale, which contains 30 items of behavior, each rated on a 5-point scale according to the frequency of occurrence by direct observation. Item scores are summarized into 6 dimension scores: memory, instrumental activities of daily life, self-care, mood, social behavior, and disturbing behavior. The NOSGER has a scoring range of 30 to 150 with the higher scores indicating worse subject's status. The items in each group are rated for their frequency ranging from 1 (never) to 5 (always). A change of <0 reveals an improvement compared to baseline. | Week 4-20 post Baseline |
| Change in the VAS Score From Baseline to Week 8, 12, 16 and/or 20. | VAS is a report device to measure the subject's burden caused by behavioral symptoms. To measure the burden on the VAS only the first 3 items of the Neuropsychiatric Inventory (NPI) Questionnaire were considered (delusions, hallucinations (visual and auditory), and agitation / aggression). The VAS consists of a 100 mm horizontal line, anchored at the ends with the reference "not at all" and "extremely". The VAS score was determined by measuring in mm from the left hand end of the line to the point, where the investigator had marked the magnitude of a subject's burden. | Week 8-20 post Baseline |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Memantine tablets, twice a day (bid).
|
|
|
| Secondary | Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20. | See #1 and #8. Change of <0 reveals a reduction of AP compared to baseline. | Intention to treat (ITT). Week 8: n=16; Week 12: n=14; Week 16: n=13; Week 20: n=15 | Posted | Mean | Standard Deviation | Percent of daily dose [DDD] | Week 8-20 post Baseline |
|
|
|
| Secondary | Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20. | MMSE is a brief, physician-administered scale, designed for measuring the cognitive functions, such as: orientation, memory, attention, naming, and comprehension. The scoring range of MMSE is 0 to 30 points. A score of 23 or lower is indicative of cognitive impairment. Change of >0 reveals an improvement compared to baseline. | Intention to treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | Week 20 post baseline |
|
|
|
| Secondary | Change of "Test for the Early Detection of Dementia With Discrimination From Depression [TE4D]" Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - First Part: Total Dementia | TE4D is a psychometric, physician-administered test that is used for both screening subjects with early dementia and monitoring the clinical progress of the disease. The first part consists of 9 items, which assess different symptoms associated with dementia such as memory, time-orientation, etc. The scoring range is 0 to 50 points. A score of 35 or lower is an indication of dementia. A change >0 represents an improvement. | Intent to treat (ITT). Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17 | Posted | Mean | Standard Deviation | units on a scale | Week 4-20 post baseline |
|
|
|
| Secondary | Change of "Test for the Early Detection of Dementia With Discrimination From Depression [TE4D]" Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - Second Part: Total Depression | TE4D is a psychometric, physician-administered test that is used for both screening subjects with early dementia and monitoring the clinical progress of the disease. The second part consists of a proxy rating and a self-assessment rating. The scoring range of each rating is 1 to 10. The maximum total score of 10 corresponds to severe depression. A change <0 reveals an improvement compared to baseline. | Intention to treat (ITT). Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17 | Posted | Mean | Standard Deviation | units on a scale | Week 4-20 post Baseline |
|
|
|
| Secondary | Change of Modified Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADLB19) Score Value From Baseline to Week 4, 8, 12, 16, and/or 20. | The modified ADCS-ADL19 is comprehensive battery of ADL questions aimed to measure the functional ability of subjects with Dementia of Alzheimer's type over a broad range of dementia severity. It has a scoring range of 0 to 54 with the lower scores indicating greater functional impairment. Each ADL item was rated from the highest level of independent performance to complete loss. Change of >0 reveals an improvement compared to baseline. | Intention to treat (ITT). Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=18 | Posted | Mean | Standard Deviation | Units on a Scale | Week 4-20 post Baseline |
|
|
|
| Secondary | Change of Nurses' Observation Scale for Geriatric Patients [NOSGER] Total Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 | NOSGER is a comprehensive scale, which contains 30 items of behavior, each rated on a 5-point scale according to the frequency of occurrence by direct observation. Item scores are summarized into 6 dimension scores: memory, instrumental activities of daily life, self-care, mood, social behavior, and disturbing behavior. The NOSGER has a scoring range of 30 to 150 with the higher scores indicating worse subject's status. The items in each group are rated for their frequency ranging from 1 (never) to 5 (always). A change of <0 reveals an improvement compared to baseline. | Intention to treat (ITT). Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17 | Posted | Mean | Standard Deviation | Units on a scale | Week 4-20 post Baseline |
|
|
|
| Secondary | Change in the VAS Score From Baseline to Week 8, 12, 16 and/or 20. | VAS is a report device to measure the subject's burden caused by behavioral symptoms. To measure the burden on the VAS only the first 3 items of the Neuropsychiatric Inventory (NPI) Questionnaire were considered (delusions, hallucinations (visual and auditory), and agitation / aggression). The VAS consists of a 100 mm horizontal line, anchored at the ends with the reference "not at all" and "extremely". The VAS score was determined by measuring in mm from the left hand end of the line to the point, where the investigator had marked the magnitude of a subject's burden. | Intention to treat (ITT). Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=18 | Posted | Mean | Standard Deviation | Units on a scale [cm] | Week 8-20 post Baseline |
|
|
|
| 2 |
| 19 |
| 7 |
| 19 |
| Agitation | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
| Sleep Disturbances | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
| Listless | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
| Sleep-related eating disorder | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
No results to be published without written agreement by sponsor; manuscripts to be sent to sponsor at least 6 weeks before submission. Sponsor to give written opinion within 30 days. Sponsor is entitled to exert influence on the contents of publications, to postpone publications up to 36 months after end of the study, and to name co-authors. In case of justified doubts of sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
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