EUCTR2020-001755-41-FR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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
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 10.6 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, for those with at least 6 years of education. MMSE range is 11-20 for participants with 5 to 6 years of education.
- •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.
- •5. Have at least 5 years of education 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 or up to 3 months prior to randomization. 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 by central read;
- •b. Fazekas scale for white matter lesions grade < 3;
- •NOTE: Computerized tomography (CT) may be allowed to substitute with similar review by central reading for MRI contraindications such as heart valve, pacemaker or implants, if medical monitor approves. CT unlike MRI would not be repeated in double-blind or OLE (see Section 8.2.7.5).
- •7. Female participants should be postmenopausal (menopause > 24 weeks), surgically sterilized, or of childbearing potential who agree to take highly effective contraceptive measures throughout the study (see Section 10.4 for details regarding contraception). Women of childbearing potential (WOCBP) must undergo a urine pregnancy test at screening and result must be negative.
- •8. May use concomitant medications at screening and during the study (see Table 6-1). These medications must be started at least 30 days before the first dose of study drug and the regimens must be planned to remain constant throughout the study.
- •9. Participants previously enrolled in an AD clinical study involving a disease modifying or symptomatic therapeutic agent may enroll in this study if: (1) AD vaccine last
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. Abnormal folate, thyroid, and/or vitamin B12 values that cannot be corrected before baseline visit.
- •3. Major structural brain disease as judged by central MRI Diagnostic Imaging Review Team (eg, ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region [eg, thalamus]). CT scan may substitute for MRI atrophy criteria if MRI is not possible.
- •4. Mental 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 impact absorption as Crohn’s, gastric bypass or recurrent diarrhea.
- •8. History or current diagnosis of significant cardiac arrhythmias, myocardial infarction, 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) after 5 minutes of rest in sitting or supine position.
- •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. History of any cancer that has been in remission (no evidence of recurrence) for > 3 years from the screening.
- •b. Participants with basal cell or stage 1 squamous cell carcinoma of the skin, stable untreated cancer as prostate or meningioma.
- •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 for more than 10 consecutive days in the last 12 weeks prior to baseline or as much as can be any projected need for more than 10 consecutive days during the course of the study. If needed for an unexpected AE during the study, the participant may continue.
- •15. May not be on AChEI or memantine for at least 4 weeks prior to first MMSE and ADAS-cog/11 at start of run-in period and throughout the study.
- •16. Past or intended use of over-the-counter or prescription medication (including herbal medications) as defined in protocol
- •17. Participants are excluded if they:
- •a. have participated in any other clinical study (excluding non-drug interventional clinical study) within 4 weeks prior to screening visit
- •b. have participated in another GV-971 clinical st
研究者
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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