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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

Page last updated: August 20, 2015

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