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

Sponsor:	Janssen Cilag Pharmaceutica S.A.C.I., Greece
Information provided by:	Janssen Cilag Pharmaceutica S.A.C.I., Greece
ClinicalTrials.gov Identifier:	NCT00297362

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
Alzheimer Disease Dementia Nervous System Diseases Mental Disorders Brain Diseases	Drug: galantamine

Study Type:	Observational
Study Design:	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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Caregivers Alzheimer's Disease Brain Diseases Caregivers Child Mental Health Dementia Mental Health Neurologic Diseases

Drug Information available for: Galantamine hydrobromide Galantamine

U.S. FDA Resources

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

Primary Outcome Measures:

Primary objective is the evaluation of safety by recording the number of patients (%) who developed AEs. Evaluation of efficacy by recording MMSE, NPI, CGI-caregiver at visit 1 & 5 [ Time Frame: Visit 1 & Visit 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of the severity and drug-drug correlation of AEs as well as of early termination due to AEs. [ Time Frame: Visits:1-5 ] [ Designated as safety issue: No ]
Evaluation of the duration of each AE in order to detect persistent AEs. [ Time Frame: Visits:1-5 ] [ Designated as safety issue: No ]
Evaluation of the effect of galantamine treatment. [ Time Frame: Visits:1-5 ] [ Designated as safety issue: No ]

Enrollment:	344
Study Start Date:	June 2004
Study Completion Date:	October 2005

Groups/Cohorts	Assigned Interventions
001	Drug: galantamine 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

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

No publications provided

Responsible Party:	Janssen Cilag Pharmaceutica S.A.C.I., Greece ( Medical Affairs Director )
Study ID Numbers:	CR003559
Study First Received:	February 24, 2006
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00297362 History of Changes
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

Additional relevant MeSH terms:

Parasympathomimetics
Nootropic Agents
Neurotransmitter Agents
Galantamine
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Brain Diseases

Neurodegenerative Diseases
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Autonomic Agents
Mental Disorders
Therapeutic Uses
Peripheral Nervous System Agents
Dementia
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009