Memantine and Antipsychotics Use
Information source: Merz Pharmaceuticals GmbH
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: Memantine (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Merz Pharmaceuticals GmbH Official(s) and/or principal investigator(s): Medical Expert, Study Director, Affiliation: Merz Pharmaceuticals GmbH
Summary
To investigate the potential to reduce concomitant antipsychotic medication use in subjects
with moderate dementia of Alzheimer's type, treated with memantine.
Clinical Details
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 design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20.Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20. 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 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 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. Change of Nurses' Observation Scale for Geriatric Patients [NOSGER] Total Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 Change in the VAS Score From Baseline to Week 8, 12, 16 and/or 20.
Eligibility
Minimum age: 50 Years.
Maximum age: 85 Years.
Gender(s): Both.
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.
Locations and Contacts
Alexianer Hospital, Krefeld, North-Rhine-Westphalia, Germany
Additional Information
Starting date: July 2008
Last updated: September 22, 2011
|