EUCTR2008-006257-40-DK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
- 198
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-hemorrhages.
- •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 drug
- •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 hematology 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 contraindicated for MRI studies 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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