Dementia of Alzheimer's Type (DAT) of all severity stages MedDRA version: 11.0 Level: LLT Classification code 10012271 Term:
Conditions
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female impatient or outpatient of at least 50 years of age 2) The patient has a diagnosis of probable Alzheimer’s disease [AD] consistent with the National Institute of Neurological and Communicative Disease and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria or with the Diagnostic and Statistical Manual Disorders (DSM IV TR) criteria for DAT. 3) Signed informed consent prior to the initiation of any study specific procedures. 4) If female, patient is at least 2 years post menopausal or surgically sterile. 5) Sight and hearing (a hearing aid is permitted) are sufficiently good to allow the undertaking of study-related procedures and psychometric tests. 6) According to the investigators opinion, the patient will be capable of completing all study-related activities. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patient is currently treated with memantine or has been treated with memantine within a period of 6 months prior to the screening visit. 2) Intake of any medications that is contra-indicated (see protocol Appendix A – Authorized/Non-Authorized medication). 3) Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine, or cardiovascular system disease (Note: patients with controlled diabetes and hypertension can be included, provided they do not use unauthorized concomitant medication). 4) Clinically significant or currently untreated B12, TSH or folate deficiency within 2 months prior to screening (Note: patients with thyroid disease may be included in the study, provided they are stable and euthyroid). 5) History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to ingredients of IMP and/or lactose. 6) Current evidence of clinically significant, unstable central nervous system or psychiatric disease (other than symptoms associated with AD) including bipolar or unipolar depression. 7) Lifetime diagnosis of psychotic disorder other than symptoms associated with Alzheimer’s disease. 8) Oncological diagnosis (hematological or solid tumor) which is currently under treatment or with evidence of active disease. 9) Known or suspected history of alcoholism or drug abuse eithin the past 2 years. 10) Participation in an investigational drug study within 60 days (or 10 half-lives of the investigational drug, whichever is longer) prior to the screening visit. 11) Any disease or medical treatment, which, according to the investigator’s judgment, could interfere with the assessments of safety, tolerability or efficacy. 12) Unwillingness or unability of the patient or the patient and his/her carers to abide by the visit schedule and other study requirements (e.g. insufficient hearing ability).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to validate the ROSA-Scale (Relevant Outcome Scale for Alzheimer Patients) content, reliability and responsiveness for detecting changes in the symptoms of the DAT disease (Dementia of Alzheimer's Type).;Secondary Objective: The secondary objective is to determine DAT severity ((Dementia of Alzheimer's Type) and other symptoms using Global Deterioration Scale [GDS], the Clinical Global Impression Scale: Global Improvement [CGI-C], Alzheimer’s Disease Assessment scale –cognitive subscale [ADAS-cog], Severe Impairment Battery [SIB], Neuropsychiatric Inventory Questionnaire [NPI-Q], Disability assessment for dementia [DAD] and to examine the times to perform these scales.;Primary end point(s): The primary variable is the ROSA-Scale. The objective is to validate the ROSA-Scale content, reliability and responsiveness for detecting changes in the symptoms of the DAT disease and to analyze the data psychometrically according to classical test theory (determination of internal consistency, test-retest reliability, construct validity, and responsiveness). | — |
Countries
Austria, Germany
Outcome results
None listed