A Study of the Safety and Effectiveness of Galantamine in Patients With Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Janssen-Cilag S.p.A.
ClinicalTrials.gov Identifier:
NCT00216502
First received: September 13, 2005
Last updated: January 20, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to evaluate the long-term efficacy and safety of galantamine in patients with Alzheimer's disease.


Condition Intervention Phase
Alzheimer Disease
Dementia
Mental Disorders
Brain Diseases
Drug: galantamine hydrobromide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Long Term Treatment With Galantamine In Dementia

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag S.p.A.:

Primary Outcome Measures:
  • Time to worsening of symptoms, defined as the time from the beginning of the double-blind portion of the study to the time of an increase in ADAS-cog score of > or = to 4 points

Secondary Outcome Measures:
  • Change in ADAS-cog, CIBIC-plus and DAD scores over time; Safety parameters assessed by adverse events; laboratory tests, vital signs, weight and ECGs.

Enrollment: 254
Study Start Date: August 2001
Study Completion Date: November 2005
Detailed Description:

Dementia is a chronic, progressive brain disease that may involve a number of symptoms, including memory loss and changes in personality, behavior, judgment, attention span, language and thought. The most common type of dementia is Alzheimer's disease. Over time, patients with Alzheimer's disease may lose ability to perform daily tasks related to personal care (for example bathing, dressing, eating) and may be unable to handle money or travel to familiar places. Previous short-term studies have shown galantamine to be safe and effective in treating patients with Alzheimer's disease, however the long-term safety and effectiveness of galantamine have not been examined. This multicenter, randomized study will assess whether long-term treatment with galantamine will delay the onset of symptoms associated with Alzheimer's disease and examine the safety and effectiveness of long-term treatment with galantamine. Patients will receive 12 months of open-label treatment with galantamine, followed by 24 months of double-blind treatment with galantamine or placebo. Safety evaluations (incidence of adverse events, physical examinations, 12 lead ECGs, vital signs, laboratory tests) will be performed throughout the study. Effectiveness will be determined using standard tests and rating scales to assess mental status, functioning, thinking, behavior, judgment and language (Mini Mental Status Exam [MMSE], Alzheimer's Disease Assessment Scale [ADAS-cog]; Disability Assessment for Dementia [DAD], and Clinician's Interview Based Impression of Changes plus Family Input [CIBIC-plus]). After the first 4 weeks, assessments will be performed every 3 months during the open-label phase (first 12 months) and then every 6 months during the double-blind phase (13-36 months). Patients whose symptoms worsen as defined by an increase of > or = to 4 points in their ADAS-cog score from the start of the double-blind phase will be withdrawn from the study. The study hypothesis is that long-term treatment with galantamine will be effective in delaying the cognitive deterioration in patients with Alzheimer's disease and that galantamine is well-tolerated with long term treatment. Galantamine 4 milligrams twice daily by mouth for 4 weeks, then 8 milligrams twice daily for 48 weeks. Thereafter, galantamine will be given as 8 milligrams twice daily for an additional 24 months.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's disease according to accepted medical standards
  • Patients with mild to moderate impairment of thinking, reasoning, and judgment as defined by a score from 11-24 on the Mini Mental Status Exam (MMSE, a standard assessment tool for Alzheimer's disease) Female patients must be post-menopausal
  • Patients and their caregivers must have signed informed consent forms Exclusion Criteria:
  • Patients with a diagnosis of Parkinson's Disease, Pick's Disease, Huntington's Chorea, Creutzfeld-Jacob disease, Down's syndrome, brain cancer, mental retardation, epilepsy, psychiatric disease, liver, kidney or heart failure, significant heart, lung, digestive, hormone or mental disease or Vitamin B deficiency
  • Patients with previous severe head injury or blood clot in the brain
  • Patients who are hospitalized, living in nursing homes or residential care facilities
  • Patients with brain infections such as abscess, meningitis, encephalitis
  • Patients with a history of drug or alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216502

Sponsors and Collaborators
Janssen-Cilag S.p.A.
Investigators
Study Director: Janssen-Cilag S.p.A. Clinical Trial Janssen-Cilag S.p.A.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00216502     History of Changes
Other Study ID Numbers: CR004996
Study First Received: September 13, 2005
Last Updated: January 20, 2011
Health Authority: Italy: National Institute of Health

Keywords provided by Janssen-Cilag S.p.A.:
Alzheimer's disease
Dementia
galantamine
placebo
Caregiver
Brain disease
Memory loss

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Mental Disorders
Psychotic Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Schizophrenia and Disorders with Psychotic Features
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014