EUCTR2019-003552-36-NL进行中（未招募）1 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 Clinical Study of CT1812 in Mild to Moderate Alzheimer’s Disease Using EEG
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
入选标准
- •1) Women of non-childbearing potential and men, aged 50 to 85 years, inclusive, with a diagnosis of mild to moderate Alzheimer’s disease according to the 2018 NIA-AA criteria and at least a 6-month history of decline in cognitive function 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) value confirming post-menopausal status may be used.
- •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 positive for amyloid beta (as defined in the study manual). Historical CSF results will be considered provided the results are consistent with the CSF amyloid beta threshold required for inclusion and following discussion with the medical monitor; however, an LP 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 Section 9.3 exclusion criteria no. 4). An historical MRI, up to 1 year prior to screening, may be used as long as there have been no interval clinical neurologic events that may suggest a change in the MRI scan.
- •4) MMSE 18-26 inclusive.
- •5) Geriatric Depression Scale (GDS) = 6 with no active depression (see Section 9.3 exclusion criteria no. 6).
- •6) Formal education of 8 or more years.
- •7) Participants must have a caregiver/study partner who in the opinion of the site’s Principal Investigator, has contact with the study participant 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 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.
- •11) Must consent to apolipoprotein E (APOE) genotyping.
- •12) Participants shall be generally healthy with mobility (ambulatory or ambulatory-aided, ie, walker or cane), vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures. 13) Must be able to complete all screening evaluations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) yes
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 system
- •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, including:
- •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 participants requiring sedation. At the discretion of the Investigator, 0.5
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