EUCTR2018-000445-39-GB进行中（未招募）1 期
A Phase II Double-Blind, Randomized, Placebo-Controlled, Adaptive Design Study to Assess the Safety, Tolerability, Immunogenicity and Target Engagement of ACI-24 Formulations in Patients with Mild 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
- 45
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 dementia according to NIA-AA core clinical criteria
- •2. Florbetaben-PET scan at screening consistent with the presence of amyloid pathology
- •3. Mini-Mental Status Examination (MMSE) 20-28 points
- •4. Age greater than or equal to 50 and less than or equal to 85 years
- •5. Patients receiving acetylcholinesterase inhibitor at a stable dose for at least 3 months prior to screening or patients not receiving acetylcholinesterase inhibitor treatment for at least 3 months prior to screening
- •6. Patients cared for by a reliable spouse or caregiver to assure compliance, assist with clinical assessments and report safety issues, and spouse or caregiver consents to serve in this role.
- •7. Women must be post-menopausal for at least one year, surgically sterilized or using reliable contraceptive measures. Male patients with partners of child bearing potential must be willing to use appropriate contraceptive measures (i.e. condoms) during the study
- •8. Patients who in the opinion of the investigator are able to understand and provide written informed consent
- •9. Patients and caregivers must be fluent in the official language(s) of the country they are living in and able to comply with all study procedures
- •10. Patients are lucid, clear and oriented x4(awareness of person, knowledge of place, time/date and event)
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1. Patients whose MRI scan (1.5 or 3T) at screening shows alternative pathology including severe vascular encephalopathy and/or more than 5 micro-hemorrhages.
- •2. Patients who meet NINDS/AIREN criteria for vascular dementia
- •3. Patients with other medical conditions which may influence cognitive performance e.g. Parkinson’s disease
- •4. Patients with any unstable medical condition (e.g. uncontrolled epilepsy, uncontrolled hypertension) and/or history of chronic or recurrent infectious or inflammatory conditions which could hamper interpretation of safety
- •5. Patients receiving memantine within 3 months prior to screening
- •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 including abuse of drug or alcohol
- •9. Significant risk of suicide defined, using the Columbia-Suicide Severity Rating Scale, as the subject answering: yes” to suicidal ideation questions 4 or 5 or answering: yes” to suicidal behavior within the past 12 months
- •10. Patients with a history of inflammatory neurological disorders including meningoencephalitis
- •11. Patients with deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, that are judged to be clinically significant by the site investigator
- •12. Patients with a history of autoimmune disease
- •13. Patients with a history of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in situ, or in-situ prostate cancer or in-situ breast cancer which have been fully removed and are considered cured
- •14. Patients who have received any vaccine within the past 2 weeks before screening
- •15. Patients who have previously received AD immune therapeutic agents, except passive immunotherapy with the last dose received at least 6 months before screening or five half-lives whichever is longer
- •16. Patients unable to undergo MRI and/or PET-scan examination for any reason, including metal implants contraindicated for MRI studies and claustrophobia; patients having contra-indication for CSF sampling
- •17. Patients with a positive HIV and/or Hepatitis B or C test at screening
- •18. Patients with positive syphilis serology
- •19. Women who are pregnant or planning to become pregnant, or who are lactating
- •20. Patients receiving any anticoagulant drug or anti-platelet therapy, except aspirin at doses of 100 mg daily or lower
- •21. Patients with a history of sustained significant behavioral disturbances secondary to Alzheimer’s disease such as hallucinations, delusions, or agitation
研究者
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