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An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer Type Dementia.
This study has been completed.
Sponsored by: Janssen Pharmaceutical K.K.
Information provided by: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00814801
  Purpose

The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease.


Condition Intervention Phase
Alzheimer's Disease
Drug: Galantamine
Other: Placebo
Phase III

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease Dementia
Drug Information available for: Galantamine hydrobromide Galantamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: Placebo-Controlled Confirmatory Study of Galantamine(R113675) for Alzheiner Type Dementia

Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Change from baseline to the end of the study in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J)

Secondary Outcome Measures:
  • Change from baseline to the end of the study in CIBIC plus-J subscales (Disability Assessment for Dementia [DAD], Behavioral Pathology in Alzheimer's Disease Rating Scale [Behave-AD], the Mental Function Impairment Scale [MENFIS ])

Estimated Enrollment: 558
Study Start Date: January 2006
Study Completion Date: September 2008
Detailed Description:

This is a randomized (assigned by chance), double-blind (neither the physician nor the patient know the name of the study medication), placebo-controlled, parallel-group study to evaluate the efficacy and safety of two fixed doses of galantamine (16 and 24 milligrams per day [mg/day]) in patients with Alzheimer's disease. The study consists of a 4-week screening period during which all patients will receive placebo, and a 24-week double-blind treatment period during which patients will receive placebo, galantamine 16 mg/day, or galantamine 24 mg/day. For patients receiving galantamine treatment, the starting dose is 8 mg/day and increases at 4-week intervals in increments of 8 mg/day. The primary measures of effectiveness are the change from baseline to the end of the study (week 24) in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J). Safety assessments include the incidence of adverse events, clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examination findings. The study hypothesis is that galantamine will be effective in the treatment of Alzheimer's disease

Study drug taken orally twice a day. 4-week screening period: All patients receive placebo. 24-week treatment period: Patients receive placebo, galantamine 16 mg/day, or 24 mg/day. For galantamine treatment, the starting dose is 8 mg/day and increases at 4-week intervals in increments of 8 mg/day.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  • Having a Mini-Mental Status Examination (MMSE) score of 10 - 22 inclusive
  • Having an Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) score of at least 18
  • Exhibiting an onset and progression of cognitive dysfunction during at least 6 months prior to the screening period

Exclusion Criteria:

  • Patients with neurodegenerative diseases other than Alzheimer's disease, such as Lewy bodies disease, (dementia due to tiny round structures made of proteins that develop within nerve cells in the brain), Parkinsonism, etc
  • Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc
  • Patients with multi-infarct dementia (brought on by a series of strokes) or active cerebrovascular disease
  • Patients with clinically significant cardiovascular disease
  • Patients currently taking drugs such as a cholinesterase inhibitors, which improve cerebral circulation/metabolism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814801

Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

Study ID Numbers: CR010297
Study First Received: December 24, 2008
Last Updated: December 24, 2008
ClinicalTrials.gov Identifier: NCT00814801  
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Janssen Pharmaceutical K.K.:
Galantamine
Alzheimer's Disease
Cognitive dysfunction

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Galantamine
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Parasympathomimetics
Nootropic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Cholinergic Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009