NL-OMON54863已完成2 期
A Randomized, Double-Blind, Placebo Controlled Study of COR388 HCl in Subjects with Alzheimer*s Disease - Study of COR388 in Subjects with Alzheimer's Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •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
- •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 visits.
- •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 criteria:
- •a. Females: Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy
- •or tubal ligation) for at least 6 months or postmenopausal (postmenopausal
- •females must have no menstrual bleeding for at least 1 year). If not
- •postmenopausal, agree to use a highly effective method of contraception, that
- •can achieve a failure rate of less than 1% per year when used consistently and
- •correctly, such as hormonal contraception or a double barrier method (e.g.,
排除标准
- •Subjects will not be eligible to participate in this study if they meet any of
- •the following exclusion criteria:
- •1. Subject has imaging consistent with other differential dementia diagnoses
- •other than the diagnosis of AD. For example, any suggestion of vascular disease
- •including multiple infarction involving large blood vessels or localized single
- •infarction (angular gyrus, thalamus, anterior cerebral artery and posterior
- •cerebral artery region), multiple lacunae of the basal nuclei or white matter
- •or extensive lesions of the periventricular white matter or combination of
- •several lesions are considered exclusionary. Additionally, any single lacune
- •in an area known to impact cognition such as the hippocampus will also be
- •exclusionary. Finally, Probable CAA with/without supporting pathological
- •evidence according to the modified Boston criteria, if in the opinion of the
- •investigator this may be contributing to symptoms overlapping with those of AD
- •or confound neuropsychological assessments, would be exclusionary.
- •Importantly, should there be any evidence of neurologic symptoms between
- •scanning and baseline visits, rescanning is necessary to ensure proper patient
- •2. Subject has had an increase or restoration of cognition based on medical
- •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 brain imaging (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, such as infected skin over the needle
- •entry site, possible increased intracranial pressure, severe thrombocytopenia
- •or coagulopathy, suspected spinal epidural abscess, or spinal structural
- •abnormalities that would interfere with LP procedures.
- •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
- •c. Current, or recent history of, any of the following that are clinically
- •significant in the investigator's judgment: arrhythmia, hypotension, heart
- •block (1st, 2nd or 3rd degree AV 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
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