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

Open Observational Study of Galantamine Hydrobromide Administration for the Treatment of Patients With Mild to Moderate Dementia of the Alzheimer Type

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Galantamine hydrobromide

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

• Study Type: Observational
• Enrollment (Actual): 344

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Galantamine hydrobromide	Drug: Galantamine hydrobromide; 247 patients with diagnosed mild to moderate Alzheimer disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in Mini-Mental State Examination (MMSE) scale scores	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.	Baseline to 6 months
Changes from baseline in Disability Assessment for Dementia (DAD) scale scores	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.	Baseline to 6 months
Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores	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.	Baseline to 6 months
Changes from baseline in Clinical Global Impression (CGI) scale scores	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".	Baseline to 6 months
Changes from baseline in Cornell Scale	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.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with Adverse Events as Measure of Safety and Tolerability	6 months
Number of patients whose vital signs fell outside the normal ranges	6 months
Number of patients whose laboratory test results fell outside the normal ranges	6 months

Collaborators and Investigators

• Sponsor: Janssen Cilag Pharmaceutica S.A.C.I., Greece

Publications and helpful links

Helpful Links

• Open Observational Study of Galantamine Hydrobromide Administration for the Treatment of Patients with Mild to Moderate Dementia of the Alzheimer Type

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Study Completion (ACTUAL): October 1, 2005

Study Registration Dates

• First Submitted: February 24, 2006
• First Submitted That Met QC Criteria: February 24, 2006
• First Posted (ESTIMATE): February 28, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): March 26, 2012
• Last Update Submitted That Met QC Criteria: March 23, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Nervous System Diseases; Dementia; Alzheimer Disease; Caregiver; Brain Disease; Mental Disorders; Memory Loss; Galantamine hydrobromide
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Parasympathomimetics; Galantamine
• Other Study ID Numbers: CR003559; 57504DEM4001 (OTHER: Janssen Cilag Pharmaceutica S.A.C.I., Greece)