Memantine - Communication Study

NCT00624026 | Completed Phase 3

• 1 other identifier: MRZ 90001-0608/1
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective is to evaluate the effects of memantine treatment on communication abilities and other cognitive abilities in moderate to severe DAT patients.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of the memantine OD IR treatment using the Consortium to establish a registry for Alzheimer's Disease (CERAD-NP) total score

  4 months

Study Arms (1)

1

EXPERIMENTAL

Drug: Memantine-HCl

Interventions

Memantine-HCl DRUG

20 mg per day (once daily)

1

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female outpatient at least 50 years of age and at least 8 years of education.
• The patient should have German as a mother-tongue or at least speak the language fluently in order to achieve similar scores in verbal tasks.
• 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.
• Mini Mental State Examination (MMSE) total score is less than 20
• Patients treated with any acetylcholinesterase inhibitor (AChEI) may be included, when treatment has started at least 6 months prior screening and was stable during the last 3 months.

You may not qualify if:

• Any type of evident aphasia, which may interfere with patient's communication difficulties caused by Alzheimer's disease
• History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to amantadine, lactose.
• 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.
• Current evidence of clinically significant systemic disease
• 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)

Central Medical Affairs

Frankfurt am Main, 60318, Germany

Location

Related Publications (1)

• Schulz JB, Rainer M, Klunemann HH, Kurz A, Wolf S, Sternberg K, Tennigkeit F. Sustained effects of once-daily memantine treatment on cognition and functional communication skills in patients with moderate to severe Alzheimer's disease: results of a 16-week open-label trial. J Alzheimers Dis. 2011;25(3):463-75. doi: 10.3233/JAD-2011-101929.

  PMID: 21471647 RESULT

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

Study Officials

• Joerg B. Schulz, MD PhD

  Center of Neurological Medicine, Goettingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 26, 2008
• Study Start: November 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 1, 2011

Record last verified: 2011-10

Locations

DE (1)