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

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

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

Intervention(s) in this Clinical Trial

• Drug: galantamine
  • 247 patients with diagnosed mild to moderate Alzheimer disease.

Arms, Groups and Cohorts in this Clinical Trial

• : 001

Primary 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
    Safety Issue?: No

Secondary 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
    Safety Issue?: No
• Evaluation of the duration of each AE in order to detect persistent AEs.
  • Time Frame: Visits:1-5
    Safety Issue?: No
• Evaluation of the effect of galantamine treatment.
  • Time Frame: Visits:1-5
    Safety Issue?: No

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

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 Investigator: Janssen Cilag Pharmaceutica S.A.C.I., Greece Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

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