Back to resultsMemantine and Antipsychotics Use (MemAP)
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Memantine
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion criteria:
- Current diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of the Alzheimer's type.
- MRI or CT scan supporting the diagnosis of DAT without indications of any relevant other CNS disorders.
- Patients treated with any acetylcholinesterase inhibitor (AChEI) man be included.
- The patient should have German as a mother-tongue or at least speak the language fluently.
Exclusion criteria:
- Evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer's disease.
- Modified Hachinski Ischemia score greater than 4 at screening.
- Intake of any medication that is contra-indicated in combination with memantine.
- Treatment with depot antipsychotics.
- History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to memantine, amantadine or lactose.
- Known or suspected history of alcoholism or drug abuse within the past 10 years.
- Previous treatment with memantine or participation in an investigational study with memantine.
Sites / Locations
- Alexianer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Memantine
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT00649220
First Posted
March 27, 2008
Last Updated
September 22, 2011
Sponsor
Merz Pharmaceuticals GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00649220
Brief Title
Memantine and Antipsychotics Use
Acronym
MemAP
Official Title
Prospective, Single-arm, Multi-centre, Open-label Study to Investigate the Potential to Reduce Concomitant Antipsychotics Use in Patients With Moderate to Severe Dementia of Alzheimer's Type (DAT) Treated With Memantine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to too slow enrollment
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the potential to reduce concomitant antipsychotic medication use in subjects with moderate dementia of Alzheimer's type, treated with memantine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Memantine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Memantine
Intervention Description
memantine tablets, twice a day (bid), for 20 weeks
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Week 8-20 post baseline
Secondary Outcome Measure Information:
Title
Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20.
Description
See #1 and #8. Change of <0 reveals a reduction of AP compared to baseline.
Time Frame
Week 8-20 post Baseline
Title
Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20.
Description
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.
Time Frame
Week 20 post baseline
Title
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
Description
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.
Time Frame
Week 4-20 post baseline
Title
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
Description
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.
Time Frame
Week 4-20 post Baseline
Title
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.
Description
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.
Time Frame
Week 4-20 post Baseline
Title
Change of Nurses' Observation Scale for Geriatric Patients [NOSGER] Total Score Value From Baseline to Week 4, 8, 12, 16, and/or 20
Description
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.
Time Frame
Week 4-20 post Baseline
Title
Change in the VAS Score From Baseline to Week 8, 12, 16 and/or 20.
Description
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.
Time Frame
Week 8-20 post Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Current diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of the Alzheimer's type.
MRI or CT scan supporting the diagnosis of DAT without indications of any relevant other CNS disorders.
Patients treated with any acetylcholinesterase inhibitor (AChEI) man be included.
The patient should have German as a mother-tongue or at least speak the language fluently.
Exclusion criteria:
Evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer's disease.
Modified Hachinski Ischemia score greater than 4 at screening.
Intake of any medication that is contra-indicated in combination with memantine.
Treatment with depot antipsychotics.
History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to memantine, amantadine or lactose.
Known or suspected history of alcoholism or drug abuse within the past 10 years.
Previous treatment with memantine or participation in an investigational study with memantine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
Merz Pharmaceuticals GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Alexianer Hospital
City
Krefeld
State/Province
North-Rhine-Westphalia
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Memantine and Antipsychotics Use
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