EUCTR2022-000080-43-ES进行中（未招募）1 期
A randomized, placebo-controlled, double-blind, parallel-group Phase 2a exploratory study with placebo run-in to investigate PK/PD effects, safety, tolerability and pharmacokinetics of REM0046127 oral suspension compared with placebo in subjects with 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）
- 发起方
- reMYND
- 入组人数
- 60
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
- •1. Mild to moderate AD as characterized by the following clinical, cognitive, and functional criteria.
- •a. Biomarker profile reflecting AD, according to The National Institute on Aging—Alzheimer's Association (NIA-AA) Research Framework based on Screening CSF Aß1-42 and p-tau concentrations
- •b. Clear EEG deficit as assessed by the EEG reader
- •c. MMSE score above 12 (preferably above 16) and a maximum of 24
- •2. A brain imaging study, such as magnetic resonance imaging (MRI) and/or computed tomography (CT) scan having been performed within last 6 months from day of the Screening visit or during the Screening phase of this study consistent with the clinical diagnosis of AD and excluding other potential causes of dementia. If there has been a significant change in clinical status suggestive of stroke or other possible central neurological disease with onset between the time of the last MRI or CT and the Screening evaluation, an MRI scan should be repeated during Screening procedures if considered appropriate by the Investigator
- •3. Age 50 to 85
- •4. BMI above 18 and below 35 kg/m2 (preferably below 30 kg/m2)
- •5. If taking concomitant medications, treated with stable doses of drugs essentially required for chronic medical conditions which do not lead to exclusion, during a period of at least 3 months prior to screening, and dose regimen is expected to remain stable during the conduct of the study
- •6. If taking an approved cholinesterase inhibitor or NMDA antagonist for treatment of Alzheimer’s disease, treated with a stable dose for at least 6 months prior to the screening visit and the dose is not expected to change during the study as per investigators judgement, or must be off such Alzheimer medication for a period of 8 weeks prior to screening
- •7. Willing and able to give informed consent.
- •8. Have a caregiver who assists the participant every day and has intimate knowledge of the participant’s cognitive, functional, and emotional states and of the participant’s personal care. The caregiver must be willing to accompany the participant to all study visits and to supervise IMP administration as well as report adverse events. The caregiver must be willing and able to give informed consent for their own participation and be able to read and write
- •9. Be able to read, write, speak clearly for the cognitive tests, with eyesight and hearing sufficient to enable completion of the cognitive tests
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. COVID-19 positive test at the screening visit
- •2. Clinical, laboratory or neuro-imaging findings consistent with:
- •i. Other primary degenerative dementia, (dementia with Lewy bodies, frontotemporal dementia, Huntington’s disease, Creutzfeldt-Jakob Disease, Down’s syndrome, etc.)
- •ii. Other neurodegenerative condition (Parkinson’s disease, amyotrophic lateral sclerosis, etc.)
- •iii. Cerebrovascular disease (major infarct, one strategic or multiple lacunar infarcts, extensive white matter lesions > one quarter of the total white matter)
- •iv. Other central nervous system diseases (severe head trauma, tumors, subdural hematoma or other space occupying processes, etc.)
- •v. Seizure disorder
- •vi. Other infectious, metabolic or systemic diseases affecting central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate
- •deficiency, serum electrolytes out of normal range, juvenile onset diabetes mellitus, etc.)
- •3. Current presence of a clinically significant major psychiatric disorder according to the criteria of the DSM-IV, or symptom that could affect the subject's ability to complete the study
- •4. Current clinically significant systemic illness, e.g., neoplasia, that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study
- •5. History of adrenal gland insufficiency
- •6. History of severe post-lumbar puncture syndrome
- •7. Abnormalities in the blood clotting system or abnormal coagulation status
- •8. Women of childbearing potential.
- •Refer to Appendix X for the definitions of woman of nonchildbearing potential.
- •9. Male subjects with female partners of child-bearing potential who are unwilling or unable to adhere to contraception requirements
- •10. Participation in another clinical study during the last 3 months
- •11. Wheelchair-bound or bed-ridden
- •12. Any other criteria which in the opinion of the Investigator causes the subject not to qualify for the study
研究者
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