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Mild to Moderate Alzheimer DiseasePhase 3NCT02293915

An Efficacy and Safety Study of Sodium Oligo-mannurarate (GV-971) Capsule for the Treatment of Alzheimer's Disease

A Phase 3 study testing Sodium oligo-mannurarate 900mg in people with Mild to Moderate Alzheimer Disease and Cognitive Impairment, run by Shanghai Greenvalley Pharmaceutical Co., Ltd. at 16 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this study is to determine the efficacy and safety of Sodium Oligo-mannurarate (GV-971) in 36-week treatment of mild to moderate Alzheimer's disease. Read more about this study

Who is it for?
Ages 50 to 85 years
What is being tested?
Sodium oligo-mannurarate 900mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
818 participants
Where
16 sitesChina
Study dates
1 Apr 2014to 28 Sep 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 50-85 years (inclusive), no gender limitation;
  • Female subjects should be postmenopausal women (menopause >24 weeks), surgically sterilized women or women of child bearing age who agree to take effective contraceptive measures during the trial. Women of child bearing age and women less than 24 weeks from menopause must undergo urine pregnancy test in screening period and result must be negative;
  • Subjects have received education in primary school and above and are able to complete protocol specified cognitive ability test and other tests;
  • Impaired memory for at least 12 months, with a tendency of progressive aggravation;
  • Meet diagnostic criteria of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) (1984);
  • Patients with mild to moderate disease, i.e. 11 ≤total MMSE score ≤26 (for subjects with primary school education, 11 ≤total MMSE score ≤22);
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  • Total Hachinski Ischemia Scale (HIS) score ≤4 ;
  • Total Hamilton Depression Scale/17-item (HAMD) score ≤10;
  • In screening, cranial MRI plain scan and oblique coronal hippocampus scan must be performed, lacunar infarction lesions with a diameter larger than 2 cm ≤2, without lacunar infarction lesion in vital sites, such as thalamus, hippocampus, entorhinal cortex, paraolfactory cortex, cortex and other subcortical gray matter nuclei; MRI shows highest possibility of Alzheimer's disease (medial temporal lobe atrophy visual rating scale MTA grade ≥2);
  • Neurological examination shows no significant sign;
  • Subjects should have stable, reliable caregivers, or at least have frequent contact with caregivers (at least 4 days every week, at least 2 h every day), and caregivers will help patients in participation in this study. Caregivers must accompany subjects to participate in study visits and have sufficient interaction and communication with subjects, so as to provide valuable information on NPI, ADCS-ADL, CIBIC-plus scales.
  • Before implementation of any protocol related procedure or examination, subjects must sign the written informed consent form. If subjects can not sign due to limited cognition, legal guardians should sign on behalf of subjects and meanwhile, legal guardians should also sign the informed consent form.

Who cannot join

  • Participate in another clinical trial within 30 days prior to initiation of this study;
  • Pregnant or nursing women;
  • Dementia due to other causes: vascular dementia, central nervous system infection (e.g. AIDS, syphilis), Creutzfeldt-Jakob disease, Huntington's chorea, Parkinson's disease, dementia with Lewy bodies, traumatic dementia, other physical and chemical factors (e.g. drug poisoning, alcoholism, carbon monoxide poisoning), significant physical illness (e.g. hepatic encephalopathy, pulmonary encephalopathy), intracranial occupying lesion (e.g. subdural hematoma, brain tumor), endocrine disorders (e.g. thyroid disease, parathyroid disease) and dementia caused by vitamin or other factors;
  • Previous nervous system disorders (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy);
  • Abnormal laboratory values: liver function (ALT, AST) > 1.5 times of upper limit of normal, Cr > 1.5 times of upper limit of normal, white blood cell count, platelet, hemoglobin below the lower limit of normal, blood glucose >1.5 times of upper limit of normal;
  • In screening, systolic blood pressure ≥160 mmHg or <90 mmHg, or diastolic blood pressure ≥100 mmHg or <60 mmHg;
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  • Unstable or severe cardiac, pulmonary, hepatic, renal or hematopoietic disease (including unstable angina, uncontrolled asthma, active gastric bleeding and cancer), after 10 min rest, resting heart rate <55 bpm;
  • Visual or hearing disorder, preventing completion of neuropsychological test and scale evaluation;
  • In screening, MRI examination shows significant focal lesions, more than 2 lacunar infarction lesions with a diameter >2 cm, lacunar infarction lesions in vital sites, such as thalamus, hippocampus, entorhinal cortex, paraolfactory cortex, cortex and other subcortical gray matter nuclei; Fazekas scale for white matter lesions at ≥ grade 3;
  • Alcohol abuse or drug abuse;
  • Patients with psychosis, including severe depression;
  • Patients who are using drugs for Alzheimer's disease which can not be stopped;
  • Use of heparin, Propylene Glycol Mannurate Sulfate or Alginric Sodium Diester within 3 weeks prior to screening;
  • Inability to take trial drugs according to prescription, previous non-compliance with prescription or possibility of non-compliance with study treatment in the trial;
  • Investigators consider subjects can not complete this study;
  • Subjects in the phase II trial of the study drug;
  • Subjects are investigators participating in this study or their direct relatives, staff of Quintiles (Shanghai) or Shanghai Greenvalley Pharmaceutical Co., Ltd. or their direct relatives.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Beijing

    Beijing, Beijing Municipality, 100005

  • Changsha

    Changsha, Hunan

  • Sichuan

    Chengdu, Sichuan, 610041

  • Chongqing

    Chongqing, Chongqing Municipality, 400010

  • Fujian

    Fuzhou, Fujian

  • Guangzhou

    Guangzhou, Guangdong

  • Hangzhou

    Hangzhou, Zhejiang, 310016

  • Jinan

    Jinan, Shandong, 250021

  • Nanjing

    Nanjing, Jiangsu

  • Shanghai

    Shanghai, Shanghai Municipality, 200030

  • Suzhou

    Suzhou, Jiangsu

  • Tianjin

    Tianjin, Tianjin Municipality, 300052

  • Wenzhou

    Wenzhou, Zhejiang

  • Wuhan

    Wuhan, Hubei, 430077

  • Xi'an

    Xi’an, Shanxi

  • Yangzhou

    Yangzhou, Jiangsu

Other trials in China

About this study

Official title: Phase III Study of Sodium Oligo-mannurarate (GV-971) Capsule on Mild to Moderate Alzheimer Disease

The primary purpose of this study is to determine the efficacy and safety of Sodium Oligo-mannurarate (GV-971) in 36-week treatment of mild to moderate Alzheimer's disease.

Being tested
Sodium oligo-mannurarate 900mg, Placebo
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium oligo-mannurarate 900mgDrug

    Also called GV-971

    sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks

  • PlaceboDrug

    simulant of sodium oligo-mannurarate capsule

Study groups in NCT02293915
Study groupRoleWhat they receive
sodium oligo-mannurarate 900mgExperimentalNot described
Receives: Drug: Sodium oligo-mannurarate 900mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of Alzheimer's Disease Assessment Scale-cognitive subscale(ADAS-cog)/12 of sodium oligo-mannurarate capsule

    Measured: 36 weeks

Secondary outcomes (4)

  1. Improvement of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) of sodium oligo-mannurarate capsule

    Measured: 36 weeks

  2. Improvement of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) of sodium oligo-mannurarate capsule

    Measured: 36 weeks

  3. Improvement of Neuropsychiatric Inventory(NPI) of sodium oligo-mannurarate capsule

    Measured: 36 weeks

  4. Glucose metabolism of bilateral temporoparietal cortex

    Obtained by Positron Emission Tomography in two sites.

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2014 (estimated)
  2. Study start1 Apr 2014
  3. Primary completion29 Jun 2018
  4. Study completion28 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
818 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02293915
Sponsor's protocol ID
971-III
Status last verified
Oct 2018
First submitted
13 Nov 2014
Last updated
10 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Ferrari C, Sorbi S. The complexity of Alzheimer's disease: an evolving puzzle. Physiol Rev. 2021 Jul 1;101(3):1047-1081. doi: 10.1152/physrev.00015.2020. Epub 2021 Jan 21.

    PubMed 33475022

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sodium oligo-mannurarate 900mg in people with Mild to Moderate Alzheimer Disease and Cognitive Impairment, run by Shanghai Greenvalley Pharmaceutical Co., Ltd. at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of Alzheimer's Disease Assessment Scale-cognitive subscale(ADAS-cog)/12 of sodium oligo-mannurarate capsule (time frame: 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02293915, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.

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