Clinical trial NCT00297362: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease
Dementia
Brain Disease
Memory Loss
Caregiver
Galantamine hydrobromide
Nervous System Diseases
Mental Disorders
Lead sponsor: Janssen Cilag Pharmaceutica S.A.C.I., Greece
Sponsor class: INDUSTRY
First posted: 2006-02-28
Enrollment: 344
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: Changes from baseline in Mini-Mental State Examination (MMSE) scale scores
timeFrame: Baseline to 6 months
measure: Changes from baseline in Disability Assessment for Dementia (DAD) scale scores
timeFrame: Baseline to 6 months
measure: Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores
timeFrame: Baseline to 6 months
measure: Changes from baseline in Clinical Global Impression (CGI) scale scores
timeFrame: Baseline to 6 months
measure: Changes from baseline in Cornell Scale
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Number of patients with Adverse Events as Measure of Safety and Tolerability
timeFrame: 6 months
measure: Number of patients whose vital signs fell outside the normal ranges
timeFrame: 6 months
measure: Number of patients whose laboratory test results fell outside the normal ranges
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag Pharmaceutica S.A.C.I.
name: Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial
role: STUDY_DIRECTOR
References: