Evaluating the effects of galantamine HBr using Goal Attainment Scaling (GAS) in a placebo-controlled trial of mild to moderate Alzheimer's disease subjects

Dalhousie University (Nova Scotia) (Canada)0 个研究点目标入组 130 人开始时间: 2005年9月1日最近更新: 2022年11月14日

适应症

试验速览

•1. Written informed consent
•2. Aged greater than or equal to 50 years old, either sex
•3. Diagnostic evidence of mild to moderate AD consistent with the national institute of neurological communicative disorders and the Alzheimer?s disease and related disorders association (NINCDS-ADRDA)
•4. A history of cognitive decline that has been gradual in onset and progressive over a period of at least 6 months
•5. A reliable carer
•6. A mini-mental state examination (MMSE) score of 10-25 inclusive at screening
•7. An Alzheimer?s disease assessment scale-cognitive section (ADAS-cog-11) score of at least 18 at screening
•8. Sufficient health based upon pre-trial physical/neurological examination

•1. Other neurodegenerative disorders
•2. Other conditions possibly resulting in cognitive impairment
•3. Multi-infarct dementia or clinically active cerebrovascular disease
•4. Coexisting medical conditions such as epilepsy, psychiatric disease, peptic ulcer, urinary outflow obstruction, or significant hepatic, renal, pulmonary, metabolic or endocrine disturbances
•5. Clinically significant cardiovascular disease
•6. Any agent used for the treatment of dementia
•7.History of drug or alcohol abuse within the last year or prior prolonged history
•8. Female subjects who are not surgically sterile or post menopausal
•9. History of severe drug allergy or hypersensitivity

发起方

Dalhousie University (Nova Scotia) (Canada)