A Study of the Safety and Effectiveness of Galantamine Hydrobromide (REMINYL®) in Patients With Alzheimer's Disease
Information source: Janssen Cilag Pharmaceutica S.A.C.I., Greece
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Diseases; Alzheimer Disease; Mental Disorders; Nervous System Diseases; Dementia
Intervention: galantamine hydrobromide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen Cilag Pharmaceutica S.A.C.I., Greece Official(s) and/or principal investigator(s):
Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial, Study Director, Affiliation: Janssen Cilag Pharmaceutica S.A.C.I., Greece
Summary
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®).
Clinical Details
Official title: Open Observational Study Of Galantamine Hydrobromide (REMINYL®) Administration For The Treatment Of Patients With Mild To Moderate Dementia Of The Alzheimer Type
Study design: Prospective
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: June 2004
Ending date: October 2005
Last updated: October 19, 2007
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