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

This study has been completed.
Sponsor:
Information provided by:
Janssen Cilag Pharmaceutica S.A.C.I., Greece
ClinicalTrials.gov Identifier:
NCT00297362
First received: February 24, 2006
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of galantamine hydrobromide in patients with Alzheimer's disease who have not received or have not responded to treatment with medication similar to galantamine hydrobromide.


Condition Intervention Phase
Alzheimer Disease
Drug: Galantamine hydrobromide
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Open Observational Study of Galantamine Hydrobromide Administration for the Treatment of Patients With Mild to Moderate Dementia of the Alzheimer Type

Resource links provided by NLM:


Further study details as provided by Janssen Cilag Pharmaceutica S.A.C.I., Greece:

Primary Outcome Measures:
  • Changes from baseline in Mini-Mental State Examination (MMSE) scale scores [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    The MMSE is a brief 30-point questionnaire test that is used to screen for cognitive impairment. A score greater than or equal to 25 points is effectively normal (intact). Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment.

  • Changes from baseline in Disability Assessment for Dementia (DAD) scale scores [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    The 40-item DAD scale assesses functional abilities in activities of daily living in patients with dementia and other cognitive impairments. Higher scores indicate less disability while lower scores denote more difficulties.

  • Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    The NPI assesses psychopathology in dementia patients. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. Both the frequency (from rarely to very often) and the severity (from mild to severe) of each behavior are determined.

  • Changes from baseline in Clinical Global Impression (CGI) scale scores [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients".

  • Changes from baseline in Cornell Scale [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    The Cornell Scale assesses signs and symptoms of major depression in patients with dementia. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 as a rule are associated with absence of significant depressive symptoms.


Secondary Outcome Measures:
  • Number of patients with Adverse Events as Measure of Safety and Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of patients whose vital signs fell outside the normal ranges [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of patients whose laboratory test results fell outside the normal ranges [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 344
Study Start Date: June 2004
Study Completion Date: October 2005
Groups/Cohorts Assigned Interventions
Galantamine hydrobromide Drug: Galantamine hydrobromide
247 patients with diagnosed mild to moderate Alzheimer disease.

Detailed Description:

Galantamine hydrobromide is a medication that is approved for the treatment of symptoms of Alzheimer's disease. In accordance with international guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety. This is a multi-center, open-label (all people involved know the identity of the intervention), observational study (individuals are observed or certain outcomes are measured - no attempt is made to affect the outcome) to collect information regarding the safety and effectiveness of galantamine hydrobromide in patients with Alzheimer's disease. Patients who have been prescribed galantamine hydrobromide as initial treatment with this type of medication for their Alzheimer's disease or who have failed previous treatment with similar medication of this type for their Alzheimer's disease will receive galantamine hydrobromide for 6 months. The individual physicians responsible for the treatment of Alzheimer's disease will administer galantamine hydrobromide at doses appropriate for each patient and will continue to oversee their care. No medication will be supplied by the sponsor of this study. Safety evaluations (incidence of adverse events, physical exams, vital signs and 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 (Neuropsychiatric Inventory, [NPI], Mini Mental Status Exam [MMSE] and Clinical Global Impression-Caregiver [CGI-Caregiver]). Assessments will be conducted monthly for the first 3 months and at the end of 6 months of treatment. Galantamine hydrobromide treatment should be discontinued if there is no further indication of effectiveness. At the end of the study, the treating physician may continue treatment with galantamine hydrobromide in responding patients as appropriate. The study hypothesis is that galantamine hydrobromide will be effective in treating the symptoms associated with Alzheimer's disease and is safe and well-tolerated. Observational study -No investigational drug administered

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

247 patients with diagnosed with mild to moderate Alzheimer's disease with a score of 10-26 on the Mini Mental Status Exam. Patients switching from an acetylcholinesterase inhibitor treatment due to lack of efficacy or poor tolerability.

Criteria

Inclusion Criteria:

  • Patients with a score of 10-26 on the Mini Mental Status Exam
  • Patients who have not yet received treatment for their Alzheimer's disease with a medication similar to galantamine or patients who have been treated with as medication similar to galantamine hydrobromide and who have discontinued that medication due to lack of effectiveness or poor tolerability (adverse events)

Exclusion Criteria:

  • Patients with severely decreased liver or kidney function
  • Patients with a digestive system or urinary blockage who are recovering from digestive system or urinary bladder surgery
  • Patients with clinically significant unstable or uncontrolled hormonal or mental disease
  • Patients who are unable to take the medication either alone or with help from another person who is available during the entire study period
  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: NCT00297362

Sponsors and Collaborators
Janssen Cilag Pharmaceutica S.A.C.I., Greece
Investigators
Study Director: Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial Janssen-Cilag Pharmaceutica S.A.C.I.
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Affairs Director, Janssen Cilag Pharmaceutica S.A.C.I., Greece
ClinicalTrials.gov Identifier: NCT00297362     History of Changes
Other Study ID Numbers: CR003559, 57504DEM4001
Study First Received: February 24, 2006
Last Updated: March 23, 2012
Health Authority: Greece: Hellenic Republic Ministry Of Health And Welfare National Organization For Medicines

Keywords provided by Janssen Cilag Pharmaceutica S.A.C.I., Greece:
Alzheimer Disease
Dementia
Brain Disease
Memory Loss
Caregiver
Galantamine hydrobromide
Nervous System Diseases
Mental Disorders

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

ClinicalTrials.gov processed this record on November 25, 2014