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CompletedPhase 2Results posted

Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease

Phase II Study of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer Disease

Lead sponsor

Shanghai Greenvalley Pharmaceutical Co., Ltd.

Asset

Sodium oligomannate

Listed sites

Recruiting sites

Enrollment

255

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≤24

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID9712011-1

NCT IDNCT01453569

Timeline

Milestones

Study start2011-10 (month precision)

Study first posted2011-10-18estimated

Primary completion2013-08actual (month precision)

Study completion2013-08actual (month precision)

Last update posted2015-01-27estimated

Results first posted2015-01-27estimated

Assets

Drug assets

Sodium oligomannate

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•At least primarily educated.

•Accord with Probable Alzheimer disease of National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA)'s Criteria.

•10 points ≤ Minimum Mean-Square Error(MMSE) ≤ 24 points.

•Hachinski ischemia scale <4 points.

•Hamilton depression scale ≤10 points.

•Should have stable accompanying person, or at least contact 2 hours per day, 4 days per week with accompanying person. The accompanying person should help the patient throughout the trial.

•Signed the information consent form

Exclusion criteria

•Have been in other clinical trials within 30 days before this trial' start.

•women during pregnancy or lactation.

•Dementia caused by other diseases.

•previous nervous system diseases.

•Abnormal laboratory results.

•Uncontrolled hypertension.

•Unstable or serious diseases of heart, lung, liver, kidney and blood.

•Visual or auditory handicap.

•Significant focal lesions revealed by electronic computer X-ray tomography(CT) or magnetic resonance imaging(MRI) in one year before enrollment.

•Alcohol abuse or drug abuse.

•psychotic, including patients with serious depression.

•Patients being in drug therapy of Alzheimer disease which cannot be stopped.

•In treatment of heparin, Polysaccharide sulfate, mannose ester 3 weeks before the recruitment.

•Investigator consider the patient cannot finish this trial for any reason.

•Relatives or employees of the investigators, staff of the investigate centers, contract research organization and sponsor.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Global cognition

Function / daily living

Global cognition

2 endpoints

Primary/protocol endpoint

Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule

Time frame:24 weeks

ADAS-Cog

descriptive

Primary/registry result

Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule

Time frame:24 weeks

ADAS-Cog

descriptive

Posted result

Group	Value (mean), units on a scale	Standard error
Sodium Oligo-mannurarate 900mgn=83 Participants	-2.58	0.62
Sodium Oligo-mannurarate 600mgn=76 Participants	-1.39	0.75
Placebon=83 Participants	-1.45	0.77

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule

Time frame:24 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule

Time frame:24 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
Sodium Oligo-mannurarate 900mgn=83 Participants	-0.49	0.91
Sodium Oligo-mannurarate 600mgn=76 Participants	-0.47	0.88
Placebon=83 Participants	-1.06	0.85

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule

Time frame:24 weeks

descriptive

Secondary/protocol endpoint

Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule

Time frame:24 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/registry result

Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule

Time frame:24 weeks

descriptive

Posted result

Group	Value (number), participants	Reported bounds
Sodium Oligo-mannurarate 900mgMarkedly improvedn=83 Participants	0	-
Moderately improvedn=83 Participants	13	-
Minimally improvedn=83 Participants	29	-
No changen=83 Participants	35	-
Minimally worsen=83 Participants	4	-
Moderately worsen=83 Participants	2	-
Markedly worsen=83 Participants	0	-
Sodium Oligo-mannurarate 600mgMarkedly improvedn=76 Participants	2	-
Moderately improvedn=76 Participants	9	-
Minimally improvedn=76 Participants	18	-
No changen=76 Participants	23	-
Minimally worsen=76 Participants	21	-
Moderately worsen=76 Participants	3	-
Markedly worsen=76 Participants	0	-
PlaceboMarkedly improvedn=83 Participants	3	-
Moderately improvedn=83 Participants	6	-
Minimally improvedn=83 Participants	32	-
No changen=83 Participants	25	-
Minimally worsen=83 Participants	17	-
Moderately worsen=83 Participants	0	-
Markedly worsen=83 Participants	0	-

Secondary/registry result

Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule

Time frame:24 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Posted result

Group	Value (mean), units on a scale	Standard error
Sodium Oligo-mannurarate 900mgn=83 Participants	-1.11	1.22
Sodium Oligo-mannurarate 600mgn=76 Participants	0.24	0.83
Placebon=83 Participants	-2.08	0.98

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Wang T, Kuang W, Chen W, Xu W, Zhang L, Li Y, Li H, Peng Y, Chen Y, Wang B, Xiao J, Li H, Yan C, Du Y, Tang M, He Z, Chen H, Li W, Lin H, Shi S, Bi J, Zhou H, Cheng Y, Gao X, Guan Y, Huang Q, Chen K, Xin X, Ding J, Geng M, Xiao S. A phase II randomized trial of sodium oligomannate in Alzheimer's dementia. Alzheimers Res Ther. 2020 Sep 14;12(1):110. doi: 10.1186/s13195-020-00678-3.
PMID32928279via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.