Memantine and Validation of a New Alzheimer's Disease Scale

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merz Pharmaceuticals GmbH

ClinicalTrials.gov Identifier:

NCT00804271

First received: December 5, 2008

Last updated: February 21, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 5, 2008

Last Updated Date

February 21, 2013

Start Date ^ICMJE

December 2008

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Validation of new scale regarding content, reliability and responsiveness for DAT symptoms [ Time Frame: at post baseline visit ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00804271 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD. [ Time Frame: at a post baseline visit ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Memantine and Validation of a New Alzheimer's Disease Scale

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: memantine

memantine tablets, OD, 12 weeks

Other Name: Axura

Study Arm (s)

Memantine

Intervention: Drug: memantine

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

487

Completion Date

November 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00804271

Other Study ID Numbers ^ICMJE

MRZ 90001/AD/3001, EudraCT No. 2008-005144-16

Has Data Monitoring Committee

Responsible Party

Merz Pharmaceuticals GmbH

Study Sponsor ^ICMJE

Merz Pharmaceuticals GmbH

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Vjera Holthoff, MD

University Clinic Gustav Carus Dresden, Germany

Information Provided By

Merz Pharmaceuticals GmbH

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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