Prospective 24-week, double-blind, randomized, placebo-controlled, multicenter study evaluating safety and change in efficacy-related surrogate parameters in patients with dementia of the Alzheimer’s type under treatment with increasing dosages of intravenous immunoglobulin (octagam® 10%)

Octapharma AG0 个研究点目标入组 56 人2008年8月7日

概览

暂无简介。

注册库

who.int

开始日期

2008年8月7日

结束日期

待定

最后更新

13年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•·Probable AD according to NINCDS\-ADRDA criteria.
•·Written informed consent by patient or, for significantly cognitively impaired individuals, their legally authorized representative.
•·Age: \>\=50 and \<\=85\.
•·MMSE: \>\=16 and \<\=26\.
•·Only for Germany: The patient’s capacity to consent has to be confirmed by dated signature on the informed consent form by a second independent investigator who is otherwise not involved in study GAM10\-04 prior to any study\-related examinations.
•·Sufficient language skills for testing.
•·Sufficient vision and hearing for testing.
•·Modified Hachinski\-Rosen Score \< 5\.
•·MRI of the head consistent with the diagnosis of AD
•·Caregiver with contact at least 4 days per week for \>\= 1 hour available.

•·Other causes of dementia (e.g. vascular dementia, Lewy Body dementia, fronto\-temporal dementia, Creutzfeld\-Jacob disease, Huntington’s disease, Parkinson’s disease).
•·History of or present significant other diseases of the central nervous system (e.g. brain tumor, normal pressure hydrocephalus, stroke, severe brain trauma, brain surgery, epilepsy, encephalitis).
•·Geriatric depression scale of \> 7 (short form with scale from 0 to 15\).
•·Present significant psychiatric disorder (e.g. major depression).
•·History of psychosis or hallucinations.
•·Mental retardation.
•·Unstable medical disease in the opinion of the investigator
•·Insulin dependent diabetes mellitus.
•·Acute infectious disease.
•·Vitamin B12 deficiency, though on stable replacement therapy for \>\= 3 months is acceptable.