Memantine and Validation of a New Alzheimer's Disease Scale

NCT00804271 | Completed Phase 3

• 2 other identifiers: MRZ 90001/AD/3001EudraCT No. 2008-005144-16
• Study Type: interventional
• Target: 487
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Validation of new scale regarding content, reliability and responsiveness for DAT symptoms

  at post baseline visit

Secondary Outcomes (1)

• Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD.

  at a post baseline visit

Study Arms (1)

Memantine

OTHER

Drug: memantine

Interventions

memantine DRUG

memantine tablets, OD, 12 weeks

Also known as: Axura

Memantine

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (1)

University Clinic Gustav Carus

Dresden, Saxony, 01307, Germany

Location

Related 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 Geriatr Psychiatry. 2013 Feb;28(2):164-72. doi: 10.1002/gps.3805. Epub 2012 Apr 11.

  PMID: 22492589 RESULT

• 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. doi: 10.1186/alzrt89.

  PMID: 21914212 RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Vjera Holthoff, MD

  University Clinic Gustav Carus Dresden, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: December 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

DE (1)