NL-OMON51880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) - GV971-007
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.0 个研究点目标入组 45 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
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. Male and female participants aged 50 to 85 years (inclusive) at the time of
- •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
- •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 by central
- •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 urin
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, thyroid, 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
- •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
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研究者
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