Memantine and Validation of a New Alzheimer's Disease Scale

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00804271
First received: December 5, 2008
Last updated: February 21, 2013
Last verified: February 2013

December 5, 2008
February 21, 2013
December 2008
November 2009   (final data collection date for primary outcome measure)
Validation of new scale regarding content, reliability and responsiveness for DAT symptoms [ Time Frame: at post baseline visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00804271 on ClinicalTrials.gov Archive Site
Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD. [ Time Frame: at a post baseline visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Memantine and Validation of a New Alzheimer's Disease Scale
Open Label, Single-Arm, Multi-Centre, Study to Validate a New Alzheimer's Disease Scale in Patients With DAT, Treated With Memantine

To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Alzheimer's Disease
Drug: memantine
memantine tablets, OD, 12 weeks
Other Name: Axura
Memantine
Intervention: Drug: memantine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
487
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of Alzheimer's type.
  • Signed informed consent prior to the initiation of any study specific procedures.
  • Sight and hearing (a hearing aid is permitted) are sufficiently good to allow the undertaking of study-related procedures and psychometric tests.

Exclusion Criteria:

  • Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
  • Intake of any medication that is contra-indicated in combination with memantine.
  • History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to ingredients of memantine or lactose.
  • Known or suspected history of alcoholism or drug abuse within the past 2 years.
  • Current or previous treatment with memantine or participation in an investigational study with memantine.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00804271
MRZ 90001/AD/3001, EudraCT No. 2008-005144-16
No
Merz Pharmaceuticals GmbH
Merz Pharmaceuticals GmbH
Not Provided
Principal Investigator: Vjera Holthoff, MD University Clinic Gustav Carus Dresden, Germany
Merz Pharmaceuticals GmbH
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP