DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Memantine and Validation of a New Alzheimer's Disease Scale

Information source: Merz Pharmaceuticals GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease

Intervention: memantine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merz Pharmaceuticals GmbH

Official(s) and/or principal investigator(s):
Vjera Holthoff, MD, Principal Investigator, Affiliation: University Clinic Gustav Carus Dresden, Germany


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

Clinical Details

Official title: Open Label, Single-Arm, Multi-Centre, Study to Validate a New Alzheimer's Disease Scale in Patients With DAT, Treated With Memantine

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Validation of new scale regarding content, reliability and responsiveness for DAT symptoms

Secondary outcome: Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD.


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

University Clinic Gustav Carus, Dresden, Saxony 01307, Germany
Additional Information

Starting date: December 2008
Last updated: February 21, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017