NL-OMON53612招募中2 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 - REMAD-02
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- ReMYND
- 入组人数
- 10
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. 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 Aβ1-42 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 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
排除标准
- •Subjects are excluded from the study if any of the following criteria apply:
- •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,
- •fronto-temporal 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
- •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 liver disease, including Gilbert*s disease or alcohol abuse
- •6. Active liver disease or jaundice, or out-of-range values of alanine
- •aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin,
- •gamma-glutamyl transferase (GGT), Alkaline Phosphatase (ALP) and/or lactate
- •dehydrogenase (LDH)
- •7. History of severe post-lumbar puncture syndrome
- •8. Abnormalities in the blood clotting system or abnormal coagulation status
- •9. Women of childbearing potential.
- •Refer to Appendix X for the definitions of woman of nonchildbearing potential.
- •10. Male subjects with female partners of child-bearing potential who are
- •unwilling or unable to adhere to contraception requirements
- •11. Participation in another clinical study during the last 3 months
- •12. Wheelchair-bound or bed-ridden
- •13. Hypersensitivity to the IMP, or components thereof, or significant drug or
- •other allergies
- •that, in the opinion of the investigator, contraindicates participation in the
- •14. 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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