EUCTR2007-007134-19-DE进行中（未招募）不适用
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%)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •·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.
- •·Outpatient status (includes Betreutes Wohnen” in Germany) or assisted living in US.
- •·Post-menopause (women) as evidenced by lack of menstruation for at least 12 consecutive months or by having bilateral oophorectomy.
- •·Stable doses of approved AD medication(s) for at least 3 months prior to screening (e.g. AChE inhibitors, memantine)
- •·Normal vital signs or clinically insignificant, if outside normal limits.
- •·Laboratory findings within normal limits or clinically insignificant, if outside normal limits.
- •·Normal ECG or clinically not significant, if outside normal limits.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·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.
- •·Unstable thyroid dysfunction, stable treated hypothyroidism for >= 3 months is acceptable, but not hyperthyroidism
- •·Uncontrolled hypertension (diastolic BP> 90 mmHg or systolic BP> 160 mmHg; sitting).
- •·Severe liver or kidney disease (ALAT > 3x upper limit of normal, creatinine > 120 µmol/L).
- •·Major surgery within three months prior to screening (e.g. heart surgery, hip replacement).
- •·Prohibited medications: antiepileptic drugs, antipsychotics, antiparkinson agents, anticholinergic drugs, selegiline, MAOI, tricyclics, immunosuppressive medications, anti-histamines (unless on a stable dose for at least 3 months), benzodiazepines, and Lithium
- •·Antidepressants are not permitted, unless if on stable dose for at least 3 months and without significant anticholinergic side-effects
- •·Potential reasons that patient may become non-evaluable during the study (e.g. planned moving into a nursing home, but assisted living is acceptable).
- •·Peripheral venous conditions, which impair establishing regular venous access for infusions
- •·Known IgA deficiency with antibodies to IgA.
- •·History of hypersensitivity to blood or plasma derived products, or any component of octagam® 10%, such as maltose.
- •·Medical conditions, which interfere with protein catabolism (e.g. nephrotic syndrome).
- •·Known blood hyperviscosity, or other hypercoagulable states.
- •·Deep vein thrombosis within preceding 4 years
- •·Symptomatic stroke
- •·Transient ischemic attack (TIA) within preceding 2 years
- •·Participation in other drug trial currently or within the previous 3 months before screening.
- •·Participation in immunological treatment studies of AD other than with IGIV within the previous 6 months before screening.
- •·IGIV use in the previous six months.
- •·Live viral vaccination within the last month before study entry.
- •·Not eligible for lumbar puncture (anticoagulant therapy, coagulation disorders, severe spinal alterations).
- •·Patients with a past or present history of drug abuse or alcohol abuse within the preceding 5 years.
- •·Patients with any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study.
研究者
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Prospective 24-week, double-blind, randomised, placebo-controlled, multicentre 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%)Alzheimer's disease (mild to moderate)Nervous System DiseasesAlzheimer's diseaseISRCTN64846759Octapharma AG (Switzerland)56
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