Phase 2
Completed N=255
Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease
Source: ClinicalTrials.gov NCT01453569 ↗Enrolled (actual)
255
Serious AEs
5.9%
Results posted
Jan 2015
Primary outcomePrimary: Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule — -2.58; -1.39; -1.45 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule |
-2.58; -1.39; -1.45 | — |
| SECONDARY Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule |
0; 2; 3; 13; 9; 6 | — |
| SECONDARY Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule |
-0.49; -0.47; -1.06 | — |
| SECONDARY Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule |
-1.11; 0.24; -2.08 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01453569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.