Clinical trial NCT00649220: Memantine and Antipsychotics Use
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Alzheimer's Disease
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the potential to reduce concomitant antipsychotic medication use in subjects with moderate dementia of Alzheimer's type, treated with memantine.


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.

Primary outcomes:
measure: 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.
timeFrame: Week 8-20 post baseline
Secondary outcomes:
measure: Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20.
timeFrame: Week 8-20 post Baseline
measure: Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20.
timeFrame: Week 20 post baseline
measure: 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
timeFrame: Week 4-20 post baseline
measure: 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
timeFrame: Week 4-20 post Baseline
measure: 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.
timeFrame: Week 4-20 post Baseline
measure: Change of Nurses' Observation Scale for Geriatric Patients [NOSGER] Total Score Value From Baseline to Week 4, 8, 12, 16, and/or 20
timeFrame: Week 4-20 post Baseline
measure: Change in the VAS Score From Baseline to Week 8, 12, 16 and/or 20.
timeFrame: Week 8-20 post Baseline
Other outcomes:
Locations:
city: Krefeld
country: Germany
facility: Alexianer Hospital
state: North-Rhine-Westphalia
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Medical Expert
role: STUDY_DIRECTOR
References: