Dementia of Alzheimer’s Type [DAT] in subjects with Mini Mental State Examination [MMSE] score 10-19 and Global Deterioration Scale [GDS] score 3-5 and antipsychotics medication during the last 3 months (at least intake at 5 days/week) MedDRA version: 10.1 Level: LLT Classification code 10012271 Term:
Conditions
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Current diagnosis of probable AD consistent with NINCDS-ADRDA criteria and with DSM IV TR criteria for DAT (precised in Appendices B and C) - Treatment with typical or atypical antipsychotic medication for at least 5 days/week during the last 3 months prior to the screening visit - If DAT treated with a cholinesterase inhibitor, treatment with a stable dose during the 3 months preceding the screening visit - MMSE score of 10-19 / GDS score of 3-5 - Signed informed consent prior to the initiation of any study specific procedures - Male or female of age = 50 years and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous or current treatment with memantine or participation in an investigational study with memantine - Treatment with depot antipsychotics - Treatment with more than 2 antipsychotic drugs at the time of study entry and during 3 months prior to the screening visit - Intake of any medication that is contra-indicated in combination with memantine (precised in SmPC) - Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease (Note, subjects with controlled diabetes and hypertension can be included, provided they do not use unauthorized concomitant medication) - Within 3 months prior to screening clinically significant or currently untreated B12, TSH or folate deficiency (subjects with thyroid disease can be included in the study, provided they are stable and euthyroid) - History of severe drug allergy, or hypersensitivity, or known hypersensitivity to amantadine and lactose - Evidence (including CT/MRI results) of any clinically significant CNS disease other than AD, especially other types of dementia (e.g. vascular type dementia, Lewy-body disease, etc.) - Modified Hachinski Ischemia score > 4 at screening (precised in Appendix D) - Current evidence of clinically significant unstable psychiatric illness (other than symptoms associated with AD) including bipolar or unipolar depression - Lifetime diagnosis of psychotic disorder other than symptoms associated with AD - Cancerous disease (hematological or solid tumor), which is currently under treatment or evidence of active disease - Known or suspected history of alcoholism or drug abuse within the past 2 years - Participation in another clinical study for an investigational medicinal product within the previous 90 days (or 5 half-lives of the investigational medicinal product, whichever is longer) prior to the screening visit or during the study - Any disease or medical treatment that can interfere with the assessment of safety, tolerability or efficacy, according to the investigator’s judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study objective is to assess the potential of reducing the use of antipsychotics in subjects with moderate DAT, treated de novo with memantine. ;Secondary Objective: The secondary efficacy objectives concern the assessment of safety parameters, the impact of memantine and antipsychotics on measures of cognitive functions, behavior, and activities of daily living. ;Primary end point(s): The primary efficacy endpoint is the maximum dose reduction of antipsychotics from baseline to a post-baseline visit in week 8, 12, 16 or 20, at which the value of the VAS is not substantially worse, compared with the baseline value. Substantially worse is defined a a deterioration of 15 % on the VAS. | — |
Countries
Germany
Outcome results
None listed