Alzheimer's Disease
Conditions
Brief summary
To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine.
Interventions
DRUGmemantine
memantine tablets, OD, 12 weeks
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Validation of new scale regarding content, reliability and responsiveness for DAT symptoms | at post baseline visit |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD. | at a post baseline visit |
Countries
Germany
Outcome results
None listed