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Clinical Trials/NCT00804271
NCT00804271CompletedPhase 3

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

Merz Pharmaceuticals GmbH1 site in 1 country487 target enrollmentStarted: December 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
487
Locations
1
Primary Endpoint
Validation of new scale regarding content, reliability and responsiveness for DAT symptoms

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Memantine

Other

Intervention: memantine (Drug)

Outcomes

Primary Outcomes

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

Time Frame: at post baseline visit

Secondary Outcomes

  • Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD.(at a post baseline visit)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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