Clinical trial NCT00814801: An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease
Official title: Placebo-controlled Confirmatory Study of Galantamine (R113675) for Alzheimer's Type Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Cognitive dysfunction
Dementia
Galantamine
R113675
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2008-12-25
Enrollment: 580
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease.

Detailed description: This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient know the name of the study medication), placebo-controlled, parallel-group study to evaluate the efficacy and safety of two fixed doses of galantamine (16 and 24 milligrams per day \[mg/day\]) in patients with Alzheimer's disease. The study consists of a 4-week screening period during which all patients will receive placebo, and a 24-week double-blind treatment period during which patients will receive placebo, galantamine 16 mg/day, or galantamine 24 mg/day. For patients receiving galantamine treatment, the starting dose is 8 mg/day and increases at 4-week intervals in increments of 8 mg/day. The primary measures of effectiveness are the change from baseline to the end of the study (week 24) in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J). Safety assessments include the incidence of adverse events, clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examination findings. The study hypothesis is that galantamine will be effective in the treatment of Alzheimer's disease. Study drug taken orally twice a day.

Eligibility criteria: Inclusion Criteria:

* Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* Having a Mini-Mental Status Examination (MMSE) score of 10 - 22 inclusive
* Having an Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) score of at least 18
* Exhibiting an onset and progression of cognitive dysfunction during at least 6 months prior to the screening period

Exclusion Criteria:

* Patients with neurodegenerative diseases other than Alzheimer's disease, such as Lewy bodies disease, (dementia due to tiny round structures made of proteins that develop within nerve cells in the brain), Parkinsonism, etc
* Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc
* Patients with multi-infarct dementia (brought on by a series of strokes) or active cerebrovascular disease
* Patients with clinically significant cardiovascular disease
* Patients currently taking drugs such as a cholinesterase inhibitors, which improve cerebral circulation/metabolism

Primary outcomes:
measure: Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)
timeFrame: Baseline and 24 weeks
measure: Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)
timeFrame: 24 weeks
Secondary outcomes:
measure: Change From Baseline in the Disability Assessment for Dementia (DAD)
timeFrame: Baseline and 24 weeks
measure: Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)
timeFrame: Baseline and 24 weeks
measure: Change From Baseline in the Mental Function Impairment Scale (MENFIS)
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Fukuoka
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K. Clinical Trial
role: STUDY_DIRECTOR
References: