NL-OMON53705招募中2 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
- 2 期
- 状态
- 招募中
- 入组人数
- 15
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
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •and at least a 6 month decline in cognitive function documented in the medical
- •i) Non-childbearing potential for women is defined as postmenopausal (last
- •menses greater than 24 months) or undergone a documented bilateral tubal
- •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
- •must agree to use condoms during the trial and for 3 months after last dose
- •the woman is using an acceptable means of birth control. Acceptable forms of
- •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.
- •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 Aβ 42
- •OR low Aβ 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
- •(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
- 另有 6 项未显示
排除标准
- •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,
- •b) Other neurodegenerative condition (Parkinson*s disease, amyotrophic lateral
- •c) Seizure disorder.
- •d) Other infectious, metabolic or systemic diseases affecting the central
- •nervous system
- •(syphilis, present hypothyroidism, present vitamin B12 or folate deficiency,
- •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
- •evaluations, such as:
- •a) Chronic liver disease, liver function test abnormalities or other signs of
- •insufficiency (ALT, AST, alkaline phosphatase > 1.5 ULN, lactate dehydrogenase
- •> 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 heart
- •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)
- •hypotension (systolic <90 mm Hg and/or diastolic <60 mm Hg).
- •g) Uncontrolled diabetes defined by HbA1c >7.5% in participants with diabetes,
- •subjects with known diabetes are required to get a HbA1c at screen.
- 另有 4 项未显示
研究者
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