EUCTR2020-001755-41-NL进行中（未招募）1 期
A Phase 3, multi-center, randomized, double-blind, parallel-group, placebo-controlled clinical trial to evaluate the efficacy and safety of sodium oligomannate (GV-971) in treatment of mild to moderate Alzheimer’s disease (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory)
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.0 个研究点目标入组 2,046 人开始时间: 2021年2月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,046
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
- 性别
- All
入选标准
- •1. Male and female participants aged 50 to 85 years (inclusive) at the time of screening.
- •2. Willing and able to give informed consent by GCP and local guidance. If the study participant is not competent to give informed consent, in the opinion of the principal investigator, a legally authorized representative (per applicable laws, rules, and regulations) must provide informed consent on his/her behalf, and the participant must provide assent (or local equivalent).
- •3. Mild to moderate AD as characterized by the following clinical, cognitive, and functional criteria per National Institute on Aging - Alzheimer’s Association (NIA-AA) diagnostic criteria (refer to Section 11.5 for additional details).
- •a. Clear history of cognitive and functional decline over at least 1 year that is either (1) documented in medical records or (2) documented by history taken from a study partner or other person who knows the participant well (eg, personal physician).
- •b. MMSE scores between 11 and 24, inclusive, at screening and at baseline.
- •Note: Screening MMSE must be performed after obtaining consent.
- •4. Have a study partner/caregiver who has known the participant for at least 1 year and assists the participant regularly at least 3 times per week and has intimate knowledge of the participant’s cognitive, functional, and emotional states and of the participant’s personal care. The study partner must be willing to accompany the participant to all study visits, assure that all of the participant’s medications and the study drug are stored and dispensed safely, and report adverse events. The study partner must be willing and able to give informed consent for their own participation, be able to read and write, and be capable of providing partner responses to scales such as ADL scales, ADCS-CGIC, and NPI.
- •Note: Use of the same study partner/caregiver during the study period is encouraged. Any change in study partner/caregiver should be recorded with reasons detailed in the medical chart and case report form (CRF). Informed consent must be obtained from the new study partner/caregiver.
- •5. Investigator confirmation of participant's ability to complete efficacy assessments and have physical, cognitive, hearing, speech, literacy, and language capacity to participate in all testing.
- •6. A brain magnetic resonance imaging (MRI) scan during screening. All imaging is evaluated by a central reader vendor (refer to imaging manual for details). MRI will have oblique coronal hippocampus scan and must show the highest possibility of AD, including:
- •a. Medial temporal lobe atrophy visual rating scale (MTA) = grade 2;
- •b. Fazekas scale for white matter lesions grade < 3;
- •NOTE: Computerized tomography (CT) may be substituted with similar review by central reading, when there are MRI contraindications such as heart valve replacement, pacemaker or implants, if medical monitor approves. CT unlike MRI would not be repeated in double-blind or OLE period(see Section 8.2.7.4).
- •7. Female participants should be postmenopausal (menopause > 24 months), surgically sterilized, or of childbearing potential who agree to take highly effective contraceptive measures throughout the study (see Section 9 for details regarding contraception). Women of childbearing potential (WOCBP) must undergo a urine pregnancy test at screening and baseline and result must be negative.
- •8. May use allowed/permitted concomitant medications at screening and during the study (see Table 6-1). These medications must keep
排除标准
- •1. Diagnosis of a dementia-related central nervous system disease other than AD (eg, Parkinson’s Disease, Huntington’s Disease, frontotemporal dementia, multi-infarct dementia, dementia with Lewy bodies, normal pressure hydrocephalus).
- •2. Abnormally low folate, and/or vitamin B12 values or evidence of hypothyroidism thought to be the cause of or to contribute to the severity of the participant's dementia.
- •3. Abnormalities found on brain MRI, including ischemic and hemorrhagic infarctions, hydrocephalus, and brain tumors will be flagged for discussion with the Medical Monitor. The NIA-AA criteria will be applied to determine if vascular lesions are exclusionary.
- •NOTE: CT scan may be substituted, with similar review by central reading when there are MRI contraindications such as heart valve replacement, pacemaker, or implants, if medical monitor approves. CT, unlike MRI, would not be repeated in double-blind or OLE period (see Section 8.2.7.4).
- •4. Mental/psychiatric illness determined by Diagnostic and Statistical Manual of Mental Disorders (DSM) V criteria, that is unstable within 12 months, or would interfere with study assessments, including schizophrenia or other psychotic disorders, bipolar disorder, severe depression, or delirium.
- •5. History of suicidal actions within the past 12 months or current suicide risk determined by a positive response (‘Yes’) to either Question 4 or Question 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening.
- •6. DSM V diagnosis of alcohol or other substance abuse dependence within the last 12 months.
- •7. Gastrointestinal illness that may substantially impact absorption such as gastric bypass or recurrent diarrhea.
- •8. History within the last 12 months or current diagnosis of clinically significant cardiovascular or cerebrovascular diseases/disorders, such as serious cardiac arrhythmias, heart rate abnormalities, myocardial infarction, well-documented transient ischemic attack, or cerebrovascular accident, uncompensated congestive heart failure New York Heart Association class III and IV.
- •9. A resting heart rate of < 50 beats per minute (bpm) by pulse or ECG, after 5 minutes of rest in sitting or supine position unless deemed not clinically significant by the Principal Investigator.
- •10. Major medical illness or unstable medical condition within 6 months of screening that in the opinion of the investigator may interfere with the participant’s ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data, including any physical disability (eg, blindness, deafness, non-AD-related speech impairment, sensory or motor dysfunction) that would prevent completion of study procedures or assessments.
- •11. Cancer except:
- •a. Cancer that has been in remission (no evidence of recurrence) for > 3 years from the screening.
- •b. Basal cell or stage 1 squamous cell carcinoma of the skin or stable untreated cancer such as prostate or meningioma.
- •c. Chronic carcinomas that do not require treatment (eg, prostate carcinoma restricted to the prostate).
- •12. Any participants who have previously been treated with GV-971 but discontinued due to safety issues or lack of efficacy.
- •13. Any participants who have taken any dose of GV-971 within 6 months prior to screening.
- •14. Use of antibiotics
- •a. For more than 10 consecutive days in the last 12 weeks prior to baseline.
- •b. When it is expected that participant will receive a treatment f
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已完成
3 期
A Phase 3, multi-center, randomized, double-blind, parallel-group, placebo-controlled clinical trial to evaluate the efficacy and safety of sodium oligomannate (GV-971) in treatment of mild to moderate Alzheimer's disease (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory)10057167Alzheimer's DiseaseNL-OMON51880Green Valley (Shanghai) Pharmaceuticals Co., Ltd.45