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OpenTrials
Completed

NCT Number: NCT00624026

Memantine - Communication Study

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

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Central Medical Affairs

Frankfurt am Main, 60318, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Memantine-HCl

Drug

20 mg per day (once daily)

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

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 26, 2008
Registry last updated
Nov 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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