Memantine and Antipsychotics Use

NCT00649220 | Terminated Phase 4 Results

• 2 other identifiers: MRZ 90001-0716/12007-004489-41
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20.

  Week 8-20 post Baseline

• Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20.

  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

  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

  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.

  Week 4-20 post Baseline

Study Arms (1)

Memantine

EXPERIMENTAL

Drug: Memantine

Interventions

Memantine DRUG

memantine tablets, twice a day (bid), for 20 weeks

Memantine

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (1)

Alexianer Hospital

Krefeld, North Rhine-Westphalia, Germany

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

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.

Results Point of Contact

• Title: Manager Public Disclosure
• Organization: Merz Pharmaceuticals GmbH

matthias.zerm@merz.de

+49 69 1503 865

Study Officials

• Medical Expert

  Merz Pharmaceuticals GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 26, 2011
• Results First Posted: September 13, 2011

Record last verified: 2011-09

Locations

DE (1)