EUCTR2019-000370-27-NL进行中（未招募）1 期
A Randomized, Double-Blind, Placebo Controlled Study of COR388 HCl in Subjects with Alzheimer’s Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 573
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. Subject has provided full written informed consent prior to the
- •performance of any protocol-specified procedure; or if unable to
- •provide informed consent due to cognitive status, subject has
- •provided assent and a legally authorized representative has
- •provided full written informed consent on behalf of the subject.
- •2. Caregiver has provided full written informed consent, on a
- •separate informed consent form (ICF), on his/her own behalf prior
- •to the performance of any protocol-specified procedure.
- •3. Male and female subjects must be 55 years to 80 years of age, at
- •the time of consent.
- •4. Subject has probable AD dementia according to the NIA-AA
- •criteria (McKhann 2011) with clinical evidence of progressive
- •cognitive decline in the last year. Clinical decline will be
- •determined based on serial cognitive test scores, if available, or
- •subject/caregiver report as documented by the Investigator.
- •5. Subject has an MMSE score between 12 and 24 inclusive at both
- •screening and Visit 2 and a =3-point difference between these
- •6. Subject has a Modified Hachinski score =4 at screening.
- •7. Subject has brain MRI scan consistent with the diagnosis of AD
- •performed during the screening period. Computed Tomography
- •scan can be used only if the subject has an absolute
- •contraindication for MRI.
- •8. Subject has a primary caregiver willing to accept responsibility for
- •supervising the treatment (e.g., administering study drug),
- •accompanying the study subject to clinic visits and assessing the
- •condition of the subject throughout the study in accordance with all
- •protocol requirements.
- •9. Subject is not likely to experience a change in living conditions
- •(e.g., institutionalization, moving to a different city, etc.), or change
- •in primary caregiver, during participation in the trial.
- •10. Subjects with background symptomatic therapy with
- •acetylcholinesterase inhibitors, and/or memantine, are allowed as
- •long as the dose has been stable for 90 days prior to screening
- •and no changes are planned during the study.
- •11. Subjects who have occasional use of sedative agents are
- •acceptable, but these agents should not be given within 48 hours
- •prior to cognitive assessments.
- •12. Subjects who have background medications used for stable
- •chronic illnesses that are not prohibited by the protocol are
- •allowed. The dose of psychoactive drugs must be stable for
- •30 days prior to screening, and no changes must be planned
- •during the study unless for safety reasons.
- •13. Subject has body mass index <38 kg/m2 at Screening.
- •14. Subject must be able to ingest oral medications and can swallow
- •the study drug without breaking or crushing.
- •15. Subject must be willing to undergo Apolipoprotein E genotype
- •(ApoE) genetic testing (ApoE results may be disclosed after trial
- •completion).
- •16. Subjects participating in the study must meet one of the following
- •a. Females: Surgically sterilized (e.g., hysterectomy, bilateral
- 另有 10 项未显示
排除标准
- •1. Subject has imaging consistent with other differential dementia diagnoses other than the diagnosis of AD.
- •2. Subject has had an increase or restoration of cognition based on medical history.
- •3. Subjects who meet the following imaging exclusion criteria will not be included in this study:
- •a. Claustrophobia that will result in significant anxiety and difficulty lying still for MRI or CT scan.
- •b. Severe motor problems or chronic pain indication that prevents the subject from lying still for brain imaging.
- •4. Subject with history of cancer requiring systemic therapy in the last 5 years; except for localized cancer of the skin and in-situ cervical cancer successfully treated with surgical excision. Stable (for at least 90 days) prostate cancer is allowed.
- •5. Subject has a contraindication for LP.
- •6. Subject has evidence of clinically significant unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurologic or metabolic disease within 6 months prior to Screening.
- •7. Subject has any of the following cardiovascular conditions:
- •a. Unstable angina, uncompensated and/or symptomatic congestive heart failure (Grade 2 or higher on the New York Heart Association scale) or myocardial infarction within 6 months.
- •b. Acute or poorly controlled blood pressure >180 mmHg systolic or >100 mmHg diastolic.
- •c. Current, or recent history of, any of the following that are clinically significant in the investigator's judgment: arrhythmia, hypotension, heart block, ANY bundle branch block, ventricular pacing, symptomatic ectopy, unstable arrhythmias including atrial fibrillation; stable atrial fibrillation is allowed.
- •d. History of prolonged QT or prolonged QT on screening ECG (QTcF >=480 msec).
- •e. History of prolonged PR interval or prolonged PR interval on screening ECG (PR >210 msec).
- •f. History of prolonged QRS interval or prolonged QRS interval on screening ECG (QRS >120 msec).
- •g. Supraventricular or ventricular ectopy on the screening ECG or Brugada pattern on the ECG.
- •8. Subject with major stroke, uncontrolled seizure disorder, or other medical illnesses that in the Investigator’s opinion will increase the subject’s risk of participation in the study or confound study assessments.
- •9. Subject with history or current evidence of major neurological or psychiatric illness such as schizophrenia, bipolar disorder, Parkinson’s Disease, etc. Subjects with major depressive disorder that may interfere with the patient’s ability to perform the study and all assessments.
- •10. Subject with history of violent or aggressive behavior that requires medication to control.
- •11. Subjects with active suicidal thoughts (Type 4 or 5 on the C-SSRS) in the 6 months preceding screening or at baseline; or have a history of a suicide attempt in the previous 2 years, or more than 1 lifetime suicide attempt; or are at serious suicide risk in the Investigator’s clinical judgment.
- •12. Subject with history of alcohol or drug use disorder within 12 months of screening .
- •13. Subject with previous treatment with investigational vaccine therapy for AD.
- •14. Subject has participated in another Investigational New Drug (IND) research study involving small molecule drugs within 60 days or biological drugs within 90 days prior to the first dose of study drug or 5 half-lives of the investigational drug, whichever is longer.
- •15. Subject has a history of epilepsy or seizure disorder requiring ongoing treatment, or any seizure or loss of consciousness within
研究者
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