Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
107 participants
INTERVENTIONAL
2007-11-30
2008-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Memantine-HCl
20 mg per day (once daily)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Memantine-HCl
20 mg per day (once daily)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
50 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merz Pharmaceuticals GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joerg B. Schulz, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Center of Neurological Medicine, Goettingen, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Central Medical Affairs
Frankfurt am Main, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MRZ 90001-0608/1
Identifier Type: -
Identifier Source: org_study_id