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CompletedNCT00624026Updated Nov 1, 2011

Memantine - Communication Study

A Phase 3 interventional study of Memantine-HCl in Alzheimer's Disease, sponsored by Merz Pharmaceuticals GmbH. Completed at 1 site in Germany. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-11-01.

Sponsored by Merz Pharmaceuticals GmbH · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
107
Allocation
Non-randomized
Ages
50 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer's Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 107 is above the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Merz Pharmaceuticals GmbH is the lead sponsor of 60 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
107 participants (actual)

Study arms

  • Experimental
    1

    Drug: Memantine-HCl

Interventions

  • DrugMemantine-HCl

    20 mg per day (once daily)

06

What researchers measure

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

07

Study locations

1 site
  • Central Medical Affairs
    Frankfurt/Main, 60318, Germany
08

References and documents

Publications

  • 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. PubMed 21471647 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00624026
Lead sponsor
Merz Pharmaceuticals GmbH
Responsible party
Sponsor
First posted
Feb 26, 2008
Start date
Nov 2007
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Nov 1, 2011

Study contacts

Joerg B. Schulz, MD PhD
principal investigator · Center of Neurological Medicine, Goettingen, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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