EUCTR2022-002326-27-NL进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CT1812 IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE - Clinical Trial of CT1812 in 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）
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Subjects may be included in the study only if they meet all of the following criteria:
- •1) Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of mild to moderate Alzheimer’s disease according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record.
- •i) Non-childbearing potential for women is defined as postmenopausal (last natural menses greater than 24 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 24 months, a serum FSH value confirming post-menopausal status can be employed.
- •ii) Male subjects who are sexually active with a woman of child-bearing potential must agree to use condoms during the trial and for 3 months after last dose unless the woman is using an acceptable means of birth control. Acceptable forms of birth control include birth control pills, or any double combination of:
- •intrauterine device (IUD), diaphragm, sponge, and cervical cap. Periodic abstinence, coitus interruptus, exclusive use of spermicides and lactational amenorrhea method (LAM) are not acceptable contraceptive methods.
- •2) Diagnostic confirmation by amyloid PET with florbetaben or another approved amyloid PET ligand. Previous amyloid imaging study with a positive result will be accepted. If none is available, then amyloid PET will be conducted during screening. Diagnostic confirmation by a CSF sample collected at the optional screening visit lumbar puncture in place of amyloid PET will also be acceptable. Inclusion via CSF samples requires: low Aß 42
- •OR low Aß 42/40 ratio AND either increased total-tau OR increased phospho-tau based on the ranges established by the central lab.
- •3) Neuroimaging (MRI, or CT scan due to contraindication of MRI is approved by Medical Monitor) obtained during screening consistent with the clinical diagnosis of Alzheimer’s disease and without findings of significant exclusionary abnormalities (see exclusion criteria, number 4). An historical MRI (or CT scan), up to 1 year prior to screening, may be used if there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs
- •suggestive of such intervening events.
- •4) MMSE 18-26 inclusive.
- •5) No active depression and a GDS =6 (see exclusion criteria number 6). Subjects with a GDS >6 may be allowed to enroll if the investigator does not believe the subject is clinically depressed. Investigators must contact the Medical Monitor to discuss eligibility.
- •6) Modified Hachinski =4.
- •7) Formal education of eight or more years.
- •8) Participants must have a caregiver/ study partner who in the opinion of the site principal investigator, has contact with the study subject for a sufficient number of hours per week to provide informative responses on the protocol assessments, oversee the administration of study drug, and is willing and able to participate in all clinic visits and some study assessments. The caregiver/ study partner must provide written informed consent to
- •participate in the study.
- •9) Participants living at home or in the community (assisted living acceptable).
- •10) Ability to swallow CT1812 capsules.
- •11) Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.
- •12) Participants must be capable of providing written informed consent to the study procedures and for use of protected h
排除标准
- •Participants will be excluded from the study if any of the following conditions apply:
- •1) Hospitalization (except for planned procedures) or change of chronic concomitant medication within one month prior to screening.
- •2) Participants living in a continuous care nursing facility.
- •3) Contraindications to the MRI examination for any reason. CT scan may be substituted for an MRI if a subject is unable to tolerate an MRI or an MRI is contraindicated for medical reasons. The proposed CT scan will be approved by the Medical Monitor on a case-by-case basis.
- •4) Screening MRI (or historical MRI, or CT scan due to contraindication of MRI if approved by medical monitor) of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct >1 cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be
- •contacted to discuss eligibility.
- •5) Clinical or laboratory findings consistent with:
- •a) Other primary degenerative dementias such as dementia with Lewy bodies, frontotemporal dementia, Huntington’s disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.
- •b) Other neurodegenerative condition (Parkinson’s disease, amyotrophic lateral sclerosis, etc.).
- •c) Seizure disorder.
- •d) Other infectious, metabolic or systemic diseases affecting the central nervous system
- •(syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other
- •laboratory values etc.).
- •6) A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder. Subjects with depressive symptoms successfully managed by a stable dose of an antidepressant or antipsychotic would be allowed to enroll.
- •7) Clinically significant, advanced or unstable disease that may interfere with outcome
- •evaluations, such as:
- •a) Chronic liver disease, liver function test abnormalities or other signs of hepatic
- •insufficiency (ALT, AST, alkaline phosphatase > 1.5 ULN, lactate dehydrogenase (LDH)
- •> 1.5 x ULN).
- •b) Respiratory insufficiency.
- •c) Renal insufficiency eGFR < 50 mL/min based on the CKD-EPI formula, as calculated by
- •the central laboratory.
- •d) Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within six months before screening).
- •e) Bradycardia (<50 beats/min or tachycardia (>100 beats/min.). If the hear rate is below 50 beats/min the subject may be eligible to enroll if the Investigator has determined that the heart rate < 50 beats/min is stable and not clinically significant. If the heart rate is above 100 beats/min, the heart rate assessment may be repeated to assess eligibility.
- •f) Poorly managed hypertension (systolic >160 mm Hg and/or diastolic >95 mm Hg) or hypotension (systolic <90 mm Hg and/or diastolic <60 mm Hg).
- •g) Uncontrolled diabetes defined by HbA1c >7.5% in participants with diabetes, Only those subjects with known diabetes are required to get a HbA1c at screen.
- •8) History of cancer within 3 years of screening with the exception of fully excised nonmelanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6
- •9) Seropositive for human immunodeficiency virus (HIV).
- •10) History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C [HCV] antibody). Su
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