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    Summary
    EudraCT Number:2020-001755-41
    Sponsor's Protocol Code Number:GV971-007
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-18
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-001755-41
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 clinical trial studying sodium oligomannate (GV-971) for treatment of patients with mild to moderate Alzheimer’s disease
    A.4.1Sponsor's protocol code numberGV971-007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04520412
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShanghai Green Valley Pharmaceutical Co., Ltd.
    B.1.3.4CountryChina
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportShanghai Green Valley Pharmaceutical Co., Ltd
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShanghai Green Valley Pharmaceutical Co., Ltd
    B.5.2Functional name of contact pointClinical Trial Medical Director
    B.5.3 Address:
    B.5.3.1Street AddressNo.421 Newton Rd, Zhangjiang Hi-tech Park, Pudong New Area
    B.5.3.2Town/ cityShanghai
    B.5.3.3Post code201203
    B.5.3.4CountryChina
    B.5.6E-mailgreenmemory@shgvp.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSodium Oligomannate
    D.3.2Product code GV-971
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium oligomannate
    D.3.9.1CAS number 2169737-52-2
    D.3.9.2Current sponsor codeGV-971
    D.3.9.3Other descriptive nameSodium oligomannate
    D.3.9.4EV Substance CodeSUB203773
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    mild to moderate Alzheimer’s disease
    E.1.1.1Medical condition in easily understood language
    mild to moderate Alzheimer’s disease
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of GV-971 compared with placebo on cognition and global function in participants with mild to moderate Alzheimer’s disease (AD).
    E.2.2Secondary objectives of the trial
    1. To assess the effect of GV-971 compared with placebo on behavioral symptoms in participants with mild to moderate AD.
    2. To assess the effect of GV-971 compared with placebo on cognitive impairment in participants with mild to moderate AD.
    3. To assess the effect of GV-971 compared with placebo on activities of daily living (ADL) in participants with mild to moderate AD.
    4. To evaluate short-term efficacy of GV-971 compared with placebo on cognition, function, and global clinical impression in participants with mild to moderate AD.
    5. To assess the safety and tolerability of GV-971 compared with placebo in participants with mild to moderate AD.
    6. To assess the effect of GV-971 on caregivers/partners of participants with mild to moderate AD.
    7. To assess the effect of GV-971 on resource utilization
    8. To assess the efficacy and safety of GV-971 throughout the open-label extension (OLE) period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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.
    Note: Screening MMSE must be performed immediately 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.
    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 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 8.2.7.4).
    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 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 dose > 12 months before baseline visit; (2)
    monoclonal antibodies last dose > 6 months before baseline visit; and
    (3) last symptomatic therapeutic agent ended > 4 weeks or 5 half-lives
    (whichever is longer) before baseline visit. These restrictions do not
    apply if the participant was assigned to placebo treatment and this is
    documented in the source documents.
    E.4Principal exclusion criteria
    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. Major CT
    scan may substitute for MRI 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 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, 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 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, stable
    untreated cancer 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 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. Use of AChEI or memantine for at least 4 weeks prior to first MMSE
    and ADAS-cog/11 and throughout the study.
    16. Use of over-the-counter or prescription medication (including herbal
    medications) not in compliance with Table 6-1
    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 study at any time
    c. plan to take part in another clinical study during this study.
    18. Geriatric Depression Scale-15 (GDS-15) total score > 7 at screening
    19. Inadequate hepatic function, defined in protocol
    20. Substantial laboratory abnormalities, defined in protocol
    21. After resting for at least 5 minutes in the supine position, 3 averaged
    ECG shows clinically significant abnormalities or QTcF > 450 ms for male
    participants and > 470 ms female participants. Exclusion applies if the
    average of the 3 exceeds these limits.
    22. After at least 5 minutes of rest in sitting or supine position (unless
    deemed not clinically significant by the Principal Investigator):
    a. systolic blood pressure (BP) > 180 mmHg
    b. diastolic BP > 100 mmHg or < 50 mmHg
    23. Poor venous access for blood samples
    24. Female participants who are pregnant or lactating. NOTE: Does not
    apply to female partners of male participants.
    25. Wherever residing, participants who do not have a reliable
    caregiver/study partner and are not able to perform basic ADL (eg,
    washing and eating) without nursing supervision.
    E.5 End points
    E.5.1Primary end point(s)
    1 Change from baseline to End of Double-blind Study (EODB) in Alzheimer’s Disease Assessments Scale – cognitive subscale/11-item (ADAS-cog/11) score.
    2 Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) scale total score at EODB.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline up to week 54
    E.5.2Secondary end point(s)
    1. Change from baseline to Weeks 36, and 52 in Neuropsychiatric
    Inventory (NPI) score.
    2. Change from baseline to EODB in Mini Mental State Examination
    (MMSE) score.
    3. End point
    • Change from baseline to Weeks 36 and 52 in Alzheimer's Disease
    Cooperative Study – Activities of Daily Living; 23-item Scale (ADCSADL23).
    • Change from baseline to Weeks 36 and 52 in Amsterdam Instrumental
    Activities of Daily Living scale (A-IADL).
    4. Change from baseline to Weeks 12, 24, and 36 in ADAS-cog/11 and
    ADCS-CGIC scores.
    5. end point
    • Incidence of treatment emergent adverse events (TEAEs) and SAEs
    • Vital signs
    • Clinical laboratory values
    • Physical exam findings
    • Electrocardiogram (ECG)
    • Columbia-Suicide Severity Rating Scale (C-SSRS)
    • Change from baseline in Zarit Burden Interview (ZBI).
    • Change from baseline in NPI caregiver items.
    6. End point
    • Change from baseline in the primary and secondary caregiver time
    components of the Resource Utilization in Dementia (RUD) – Lite Version
    • The change from baseline in the RUD-Lite total score
    7. Changes from baseline through End of Study (EOS) and from Week 52 to Week 78 in:
    o ADAS-cog/11,
    o ADCS-CGIC,
    o NPI,
    o MMSE,
    o ADCS-ADL23,
    o A-IADL,
    o Incidence of adverse events (AEs),
    o Vital signs,
    o Clinical laboratory values,
    o Physical exam findings,
    o Electrocardiogram (ECG),
    o Columbia-Suicide Severity Rating Scale (C-SSRS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoint ;
    1 baseline to week 36 and 52
    2 baseline to week 54
    3 baseline to Weeks 36 and 52
    4 baseline to Weeks 12, 24, and 36
    5 to 6 baseline to End of Study
    7 baseline through End of Study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    China
    Czechia
    France
    Germany
    Hong Kong
    Italy
    Netherlands
    Poland
    Spain
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1228
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 818
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    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.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state125
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 496
    F.4.2.2In the whole clinical trial 2046
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No further provisions are made for access to the study treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-20
    P. End of Trial
    P.End of Trial StatusOngoing
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