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OpenTrials
Completed

NCT Number: NCT00804271

Memantine and Validation of a New Alzheimer's Disease Scale

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Clinic Gustav Carus

Dresden, Saxony, 01307, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Memantine

Drug

memantine tablets, OD, 12 weeks

Other names: Axura

Primary outcomes

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

    Time frame: at post baseline visit

Secondary outcomes

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

    Time frame: at a post baseline visit

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 8, 2008
Registry last updated
Feb 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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