Memantine and Validation of a New Alzheimer's Disease Scale

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804271
• Other study ID #: MRZ 90001/AD/3001
• Secondary ID: EudraCT No. 2008
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2008
• Last updated: February 21, 2013
• Start date: December 2008
• Est. completion date: November 2009

Study information

• Verified date: February 2013
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 487
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• memantine
memantine tablets, OD, 12 weeks

Locations

Country	Name	City	State
Germany	University Clinic Gustav Carus	Dresden	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Holthoff V, Ferris S, Gauthier S, Ihl R, Robert P, Winblad B, Sternberg K, Tennigkeit F; ROSA Study Group. Memantine effects measured with the Relevant Outcome Scale for Alzheimer's disease in an open-label, single-arm, multicenter clinical study. Int J G — View Citation

Holthoff VA, Ferris S, Ihl R, Robert P, Winblad B, Gauthier S, Sternberg K, Tennigkeit F. Validation of the relevant outcome scale for Alzheimer's disease: a novel multidomain assessment for daily medical practice. Alzheimers Res Ther. 2011 Jul 6;3(5):27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of new scale regarding content, reliability and responsiveness for DAT symptoms		at post baseline visit	No
Secondary	Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD.		at a post baseline visit	No