Open-label, single-arm, multi-center validation study of the ROSA-Scale (Relevant Outcome Scale for Alzheimer Patients) in patients with dementia of Alzheimer’s type (DAT) treated with memantine over a 3 months period - ROSA Validation Study

• Conditions: Dementia of Alzheimer's Type (DAT) of all severity stages; MedDRA version: 11.0Level: LLTClassification code 10012271Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2008-005144-16-AT
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-17
• Last Update Posted: 12 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1) Male or female 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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified