Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease with Option for an Additional Two years of Treatment.

F. Hoffmann-La Roche Ltd0 个研究点目标入组 797 人开始时间: 2010年10月20日最近更新: 2020年11月9日

适应症

试验速览

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•- Adult patients, 50-85 years of age
•- Patients with prodromal Alzheimer's Disease who are not receiving memantine or cholinesterase inhibitors
•- Has a study partner who is able to provide accurate information as to the patient's cognitive and functional abilities, who agrees to provide information at clinic visits which require partner input for scale completion
•- Has had sufficient education or work experience to exclude mental retardation
•- Study partner has noticed a recent gradual decrease in the patient's memory (e.g. over the last 12 months), which the patient may or may not be aware of.
•- Screening MMSE score of 24 or above
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 154
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 616

•- Other prior or current neurologic or medical disorder which may currently or during the course of the study impair cognition or psychiatric functioning
•- A history of stroke
•- A documented history of transient ischemic attack within the last 12 months
•- History of schizophrenia, schizoaffective disorder or bipolar disorder
•- Currently meets criteria for major depression
•-Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g. myocardial infarction, angina pectoris)

发起方