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

Sponsored by:	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 (REMINYL®) in patients with Alzheimer's disease who have not received or have not responded to treatment with medication similar to galantamine hydrobromide (REMINYL®).

Condition	Intervention	Phase
Brain Diseases Alzheimer Disease Mental Disorders Nervous System Diseases Dementia	Drug: galantamine hydrobromide	Phase IV

Study Type:	Observational
Study Design:	Prospective
Official Title:	Open Observational Study Of Galantamine Hydrobromide (REMINYL®) 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 Disease Brain Diseases 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:

Estimated Enrollment:	320
Study Start Date:	June 2004
Estimated Study Completion Date:	October 2005

Detailed Description:

Galantamine hydrobromide (REMINYL®) 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 observational study to collect information regarding the safety and effectiveness of galantamine in patients with Alzheimer's disease. Patients who have been prescribed galantamine hydrobromide (REMINYL®) 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 for 6 months.

The individual physicians responsible for the treatment of Alzheimer's disease will administer galantamine 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 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 in responding patients as appropriate. The study hypothesis is that galantamine will be effective in treating the symptoms associated with Alzheimer's disease and is safe and well-tolerated.

For patients who are new to exposure to an AChE (acetylcholinesterase) inhibitor, Reminyl will be administered according to the following schedule: Week

1 - 4: 4mg galantamine twice daily; Week 5 - 8: 8mg galantamine twice daily; Week 9 - 12: 12mg galantamine twice daily. Study duration: 6 Months.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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., Greece

More Information

No publications provided

Study ID Numbers:	CR003559
Study First Received:	February 24, 2006
Last Updated:	October 19, 2007
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:

Memory Loss
Dementia
Alzheimer Disease

Caregiver
Galantamine hydrobromide
Brain Disease

Study placed in the following topic categories:

Nootropic Agents
Neurotransmitter Agents
Galantamine
Alzheimer Disease
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Cholinergic Agents

Cognition Disorders
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Peripheral Nervous System Agents
Dementia
Amnesia
Delirium

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 July 02, 2009