NL-OMON54794已完成2 期
A Pilot Electroencephalography (EEG) Study to Evaluate the Effect of CT1812 Treatment on Synaptic Activity in Subjects With Mild to Moderate Alzheimer*s Disease - Pilot Study of CT1812 in Mild to Moderate AD Using EEG
Julius Clinical0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
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
- •Participants may be included in the study only if they meet all the following
- •1) Women of non-childbearing potential and men, aged 50 to 85 years, inclusive,
- •diagnosis of mild to moderate Probable Alzheimer*s Disease Dementia, according
- •the NIA-AA 2018 criteria and at least a 6-month history of decline in cognitive
- •documented in the medical record.
- •i) Non-childbearing potential for women is defined as postmenopausal (last
- •menses greater than 24 months) or undergone a documented bilateral tubal
- •ligation or hysterectomy. If last menses less than 24 months, a serum follicle
- •stimulating hormone (FSH) confirming post-menopausal status will be
- •determined.
- •ii) Male participants who are sexually active with a woman of child-bearing
- •potential must agree to use condoms during the study and for 3 months after
- •last dose. Female partners should also consider using an acceptable means of
- •birth control, though it is not mandatory. Acceptable forms of birth control
- •include abstinence, birth control pills, or any double combination of:
- •intrauterine device (IUD), male or female condom, diaphragm, sponge, and
- •cervical cap.
- •2) CSF meets CSF abeta 1*42 (abeta) and p-tau -181 criteria as defined below.
- •CSF abeta 1*42 < 1000pg/ml (Elecsys assay) AND
- •CSF p*tau 181 > 19 pg/ml (Elecsys Assay)
- •CSF abeta 1*42 < 1000pg/ml (Elecsys assay) AND
- •p*tau *181 / abeta 1*42 ratio > 0.020
- •CSF p*tau 181 > 19 pg/ml (Elcsys Assay) AND
- •p*tau *181 / abeta 1*42 ratio > 0.020
- •Historical CSF results will be considered provided the results are consistent
- •CSF thresholds required for inclusion and following discussion with the medical
- •monitor; however, a lumbar puncture is still required as part of screening
- •procedures.
- •3) Neuroimaging (MRI) consistent with the clinical diagnosis of Alzheimer*s
- •disease and
- •without findings of significant exclusionary abnormalities (see exclusion
- •number 4). A historical MRI, up to 1 year prior to screening, may be used as
- •there have been no interval clinical neurologic events which may suggest a
- •the MRI scan.
- •4) MMSE score of 18 to 26, inclusive.
- •5) No active depression and a GDS <= 6 (see exclusion criteria number 6).
- •6) Formal education of 8 or more years.
- •7) Participants must have a caregiver/ study partner who in the opinion of the
- •Principal Investigator, has contact with the study participant for a sufficient
- •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
- •study site visits and some study assessments. The caregiver/study partner must
- •provide written informed consent to participate in the study.
- •8) Participants living at home or in the community (assisted living
- •acceptable).
- •9) Participants must have no known history of difficulty swallowing capsules.
- •10) Stable pharmacological treatment of any other chronic conditions for at
- •least 30 days
- •prior to screening.
- 另有 4 项未显示
排除标准
- •1) Hospitalization (except for planned procedures) or change of chronic
- •concomitant medication within 1 month prior to screening
- •2) Participants living in a continuous care nursing facility
- •3) Contraindications to the MRI examination for any reason
- •4) Screening MRI (or historical MRI, if applicable) 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
- •5) Clinical or laboratory findings consistent with:
- •-Other primary degenerative dementia
- •-Other neurodegenerative condition
- •-Seizure disorder
- •-Other infectious, metabolic or systemic diseases affecting the central nervous
- •6) A current DSM-V diagnosis of active major depression, schizophrenia or
- •bipolar disorder. Participants with depressive symptoms successfully managed by
- •a stable dose of an antidepressant are allowed entry.
- •7) Clinically significant, advanced or unstable disease that may interfere with
- •outcome evaluations, such as:
- •-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).
- •-Respiratory insufficiency.
- •-Renal insufficiency eGFR < 50 mL/min based on the CKD-EPI formula,
- •https://www.mdcalc.com/ckd-epi-equations-glomerular-filtration-rate-gfr
- •-Heart disease.
- •-Bradycardia (< 50/min.) or tachycardia (> 100/min.).
- •-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)
- •-Uncontrolled diabetes in known diabetics, as defined by hemoglobin A1c > 7.5
- •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 months
- •9) Seropositive for human immunodeficiency virus
- •10) History of acute/chronic hepatitis B or C and/or carriers of hepatitis B
- •11) Clinically significant abnormalities in screening laboratory tests,
- •Hematocrit less than 35% for males and less than 32% for females, absolute
- •neutrophil cell count of <1500/uL (with the exception of a documented history
- •of a chronic benign neutropenia), or platelet cell count of < 120,000/uL;
- •INR > 1.4 or other coagulopathy, confirmed by repeat assessment of:
- •-Hematocrit
- •-Neutrophil count
- •-Platelet count
- •12) Disability that may prevent the participant from completing all study
- •requirements
- •13) Within 4 weeks of screening visit or during the study, concurrent treatment
- •with antipsychotic agents, antiepileptics, centrally active anti-hypertensive
- •drugs, sedatives, opioids, mood stabilizers; or benzodiazepines, with the
- •following exception:
- •-Low dose lorazepam may be used for sedation prior to MRI scan for those
- 另有 5 项未显示
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