EUCTR2008-006257-40-SE进行中（未招募）1 期
A Phase I/II Double-Blind, Randomised, Placebo-Controlled, Adaptive Design Study of the Safety, Tolerability, Immunogenicity and Efficacy of ACI-24 in Patients with Mild to Moderate Alzheimer's Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- AC Immune SA
- 入组人数
- 48
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
- •1. Probable AD according to NINCDS-ADRDA criteria
- •2. Florbetaben-PET scan at screening consistent with the presence of amyloid pathology
- •3. Mini-Mental Status Examination (MMSE) 18 – 28 points*
- •4. Age over 40 and less than 90 years**
- •5. Patients receiving a stable dose of an acetylcholinesterase inhibitor for at least 4 months prior to baseline
- •6. Patients cared for by a reliable spouse or caregiver to assure compliance, assist with clinical assessments and report safety issues
- •7. Women must be post-menopausal for at least one year, surgically sterilized or using reliable contraceptive measures
- •8. Patient who in the opinion of the investigator are able to understand and provide written informed consent
- •9. Patients and caregivers must be fluent in one of the languages of the study and able to comply with all study procedures
- •10. The patient is lucid and clear and oriented x4 and is able to provide their written informed consent (applicable in Sweden only).
- •* For cohort 3 booster injection, the previous lower limit of 18 points for the MMSE will not be required but in all cases patients must be oriented in time, place, person and current activities and able to give informed consent in the opinion of the investigator in order to take part.
- •** For cohort 3 booster injection, no upper age limit applies.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •1. Patients whose MRI scan within the last 6 months shows alternative pathology including severe vascular encephalopathy and/or more than 5 micro-haemorrhages.
- •2. Patients with other medical conditions which may influence cognitive performance e.g. Parkinson’s disease
- •3. Patients with any unstable medical condition (e.g. epilepsy, uncontrolled hypertension) which would hamper safety assessments
- •4. Patients receiving memantine within 3 months prior to baseline (for cohort 3 booster injection, memantine is allowed)
- •5. Patients receiving any anticoagulant drugs
- •6. Patients with a history of hemorrhagic stroke
- •7. Patients with a history of non-hemorrhagic stroke or myocardial infarction within the last year
- •8. Patients with a history of major psychiatric disorder within the past 2 years
- •9. Patients with a history of inflammatory neurology disorders including meningoencephalitis
- •10. Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal of SGOT, SGPT, or creatinine
- •11. Patients with a history of autoimmune disease
- •12. Patients with a history of cancer other than skin cancer within the past 5 years
- •13. Patients who have received any vaccine within the past 2 months before baseline
- •14. Patients who have previously received AD immune therapeutic agents or vaccines
- •15. Patients anticipated to receive any vaccination other than influenza vaccine during the study
- •16. Patients unable to undergo MRI examination for any reason, including metal implants and claustrophobia
- •17. Patients with a positive HIV test at screening
- •18. Patients with positive syphilis serology
- •19. Women who are pregnant or planning to be pregnant, or who are lactating
研究者
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