|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00624026 |
|
Date of registration:
|
14/02/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Memantine - Communication Study
|
|
Scientific title:
|
Prospective, Single-arm, Multicenter, Open-label Study to Investigate the Efficacy and Tolerability of the Once Daily (OD) Memantine Treatment |
|
Date of first enrolment:
|
November 2007 |
|
Target sample size:
|
107 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00624026 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Joerg B. Schulz, MD PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Center of Neurological Medicine, Goettingen, Germany |
| | |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
50 Years
Age maximum:
90 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Alzheimer's Disease
|
|
Intervention(s)
|
|
Drug: Memantine-HCl
|
|
Primary Outcome(s)
|
|
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]
|
|
Secondary ID(s)
|
|
MRZ 90001-0608/1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|