Clinical Trials List
Protocol NumberGV971-007
NCT Number(ClinicalTrials.gov Identfier)NCT04520412
2020-12-15 - 2022-06-30
Phase III
Not yet recruiting1
Recruiting1
Terminated1
ICD-10G30.0
Alzheimer's disease with early onset
ICD-10G30.1
Alzheimer's disease with late onset
ICD-10G30.8
Other Alzheimer's disease
ICD-10G30.9
Alzheimer's disease, unspecified
ICD-9331.0
Alzheimer's disease
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)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
-
Sponsor
Shanghai Green Valley Pharmaceutical Co., Ltd.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- HUNG-KUANG SU Division of Psychiatry
- YI-TING LIN Division of Psychiatry
- 謝明憲 Division of Psychiatry
- YA-FANG CHEN Division of Radiology
- Chen-Chung Liu Division of Psychiatry
- 陳宜明 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chi-Hung Liu Division of Neurology
- KuoLun Huang Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Alzheimer’s disease
Objectives
This study is designed to provide further data including biomarkers and long-term efficacy and safety analyses that will show GV-971 effect on AD progression.
Test Drug
GV-971
Active Ingredient
sodium oligomannate
Dosage Form
Caple
Dosage
150
Endpoints
Change from baseline to End of
1.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
1.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
Inclution 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 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 dose > 12
months before baseline visit; (2) monoclonal antibodies last dose > 6 months before baseline
visit; and (3) last symptomatic therapeutic agent ended > 1 month 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. Previous rejected participants from another study may permitted if their data are discussed with the
medical monitor.
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 dose > 12
months before baseline visit; (2) monoclonal antibodies last dose > 6 months before baseline
visit; and (3) last symptomatic therapeutic agent ended > 1 month 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. Previous rejected participants from another study may permitted if their data are discussed with the
medical monitor.
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. 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.
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.
The Estimated Number of Participants
-
Taiwan
52 participants
-
Global
2046 participants
