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

NCT00297362 | Completed

• 2 other identifiers: CR00355957504DEM4001
• Study Type: observational
• Target: 344
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; Dementia; Brain Disease; Memory Loss; Caregiver; Galantamine hydrobromide; Nervous System Diseases; Mental Disorders

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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

Study Arms (1)

Galantamine hydrobromide

Drug: Galantamine hydrobromide

Interventions

Galantamine hydrobromide DRUG

247 patients with diagnosed mild to moderate Alzheimer disease.

Galantamine hydrobromide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related Links

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

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Memory Disorders; Nervous System Diseases; Mental Disorders

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial

  Janssen-Cilag Pharmaceutica S.A.C.I.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 28, 2006
• Study Start: June 1, 2004
• Study Completion: October 1, 2005
• Last Updated: March 26, 2012

Record last verified: 2012-03