Memantine - Communication Study

Alzheimer's Disease Clinical Trial

Official title:

Prospective, Single-arm, Multicenter, Open-label Study to Investigate the Efficacy and Tolerability of the Once Daily (OD) Memantine Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624026
• Other study ID #: MRZ 90001-0608/1
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2008
• Last updated: October 31, 2011
• Start date: November 2007
• Est. completion date: December 2008

Study information

• Verified date: October 2011
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Austrian Agency for Health and Nutrition Security, Section Pharm. Med.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Memantine-HCl
20 mg per day (once daily)

Locations

Country	Name	City	State
Germany	Central Medical Affairs	Frankfurt/Main

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schulz JB, Rainer M, Klünemann 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-wee — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No