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Alzheimer DiseasePhase 2NCT01453569

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

A Phase 2 study testing Sodium oligo-mannurarate 600mg and Sodium oligo-mannurarate 900mg in people with Alzheimer Disease and Cognitive Impairment, run by Shanghai Greenvalley Pharmaceutical Co., Ltd. at 24 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 whether sodium oligo-mannurarate capsule is effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine the best therapeutic dose of sodium oligo-mannurarate capsule. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer Disease, Cognitive Impairment
What is being tested?
Sodium oligo-mannurarate 600mg and 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
255 participants
Where
24 sitesChina
Study dates
Oct 2011to Aug 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

China24 sites

  • The Central Hospital of Baotou

    Baotou, Inner Mongolia, 014040

  • Beijing Hospital

    Beijing, Beijing Municipality, 100005

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005

  • West China Hospital, West China School of Medicine Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing Medical University Second Affiliated Hospital

    Chongqing, Chongqing Municipality, 400010

  • The First Affliated Hospital of Third Military Medical University

    Chongqing, Chongqing Municipality, 400038

  • The Third Affliated Hospital of Third Military Medical University

    Chongqing, Chongqing Municipality, 400042

  • Guangzhou Brain Hospital

    Guangzho, Guangdong, 510170

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510120

  • Sir Run Run Shaw Hospital, Medical college of Zhejiang University

    Hangzhou, Zhejiang, 310016

  • The First Affliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • The Second Hospital of Shandong University

    Jinan, Shandong, 250033

  • The Affliated Brain Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • The Ninth Hospital, Shanghai Jiao Tong University school of Medicine

    Shanghai, Shanghai Municipality, 200011

  • Shanghai Mental Health Center , Shanghai Jiao Tong University school of Medicine

    Shanghai, Shanghai Municipality, 200030

  • The First Affliated Hospital of Chinese Medical University

    Shenyang, Liaoning, 110001

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Wuhan General Hospital of Guangzhou Military of People's Military Army

    Wuhan, Hubei, 430070

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430077

  • Wuxi Mental Health Center

    Wuxi, Jiangsu, 214151

  • Tangdu Hospital of The Forth Military Medical University of PLA

    Xi’an, Shanxi, 710038

  • The 251 Hospital of People's Liberation Army

    Zhangjiakou, Hebei, 075000

Other trials in China

About this study

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

The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine the best therapeutic dose of sodium oligo-mannurarate capsule.

Read the detailed description

Alzheimer's disease is known for placing a great burden on caregivers which includes social, psychological, physical or economic aspects. Research indicates that the disease is associated with plaques and tangles in the brain. Currently used treatments offer a small symptomatic benefit. No treatments to delay or halt the progression of the disease are, as of yet, available. The investigators suppose sodium oligo-mannurarate capsule to be effective to halt the progression of the disease.

Being tested
Sodium oligo-mannurarate 600mg, Sodium oligo-mannurarate 900mg, Placebo
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

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

  • Sodium oligo-mannurarate 600mgDrug

    Also called Sodium oligo-mannurarate low dose

    sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks

  • Sodium oligo-mannurarate 900mgDrug

    Also called Sodium oligo-mannurarate high dose

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

  • PlaceboDrug

    simulant of sodium oligo-mannurarate capsule

Study groups in NCT01453569
Study groupRoleWhat they receive
sodium oligo-mannurarate 900mgExperimentalNot described
Receives: Drug: Sodium oligo-mannurarate 900mg
sodium oligo-mannurarate 600mgExperimentalNot described
Receives: Drug: Sodium oligo-mannurarate 600mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

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

    Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 is the most popular cognitive testing instrument used in clinical trials. It consists of 12 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. The total score ranges 0-75, the higher score indicates more severity of the disease. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.

    Measured: 24 weeks

Secondary outcomes (3)

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

    Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) is widely used in antidementia drug trials. It comprises Likert scales for disease severity and changes, and written accounts summarizing semistructured interviews evaluating behavior, cognition, and function. The results classified as 7 degrades as: Markedly improved, Moderately improved, Minimally improved, No change, Minimally worse, Moderately worse, and Markedly worse.

    Measured: 24 weeks

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

    Alzheimer's Disease Cooperative Study/Activities of Daily (ADCS-ADL) is a scale assessed the daily activties of AD patients after interviewed the caregiver. The scale mainly assess the eating, walking, writing, bathing and reading, et al of the subject. The total score ranges 0-78, the higher score indicate improvement in daily activities. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a positive change represents an improvement.

    Measured: 24 weeks

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

    Neuropsychiatric Inventory (NPI) is a scale to obtain information on the presence of psychopathology in patient with brain disorders. The NPI was developed for application to patients with AD and other dementias, but it may be useful in the assessment of behavioral changes in other conditions. Twelve behavioral areas included in the NPI will be assessed in this trial: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety and elation/euphoria, et al. The total score ranges 0 to 120, the higher score indicates worse state of the AD patient. Change after 24wks treatmnt was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.

    Measured: 24 weeks

Timeline

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

  1. First posted18 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionAug 2013
  4. Study completionAug 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01453569
Sponsor's protocol ID
9712011-1
Status last verified
Jan 2015
First submitted
30 Sep 2011
Last updated
27 Jan 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 32928279

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sodium oligo-mannurarate 600mg and Sodium oligo-mannurarate 900mg in people with Alzheimer Disease and Cognitive Impairment, run by Shanghai Greenvalley Pharmaceutical Co., Ltd. at 24 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 7 inclusion and 15 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 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

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). 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 NCT01453569, 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 27 Jan 2015.

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