Official Title: “Open Observational Study Of Galantamine Hydrobromide (REMINYL®) 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 (REMINYL®) in patients with Alzheimer's disease who have not received or have not responded to treatment with medication similar to galantamine hydrobromide (REMINYL®).

Study Type: Observational

Study Design: Prospective

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.

Intervention(s) in this Clinical Trial

• Drug: galantamine hydrobromide

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

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

Overall Clinical Trial Officials and Contacts

Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial Study Director Janssen Cilag Pharmaceutica S.A.C.I., Greece  

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00297362

Study ID Number: CR003559

ClinicalTrials.gov Identifier: NCT00297362

Health Authority: Greece: Hellenic Republic Ministry Of Health And Welfare National Organization For Medicines