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Study of Octohydroaminoacridine Succinate Tablets in Patients With Alzheimer's Disease
A Phase II, Double Blind, Placebo-controlled, Randomized, Multi-Center, Parallel Group Dose Exploring Study to Evaluate the Efficacy and Safety of Octohydroaminoacridine Succinate Tablets in Patient With Mild to Moderate Alzheimer's Disease
Lead sponsor
Asset
Octohydroaminoacridine succinate
Listed sites
13
Recruiting sites
13
Enrollment
288
estimated
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE ≤25
Primary endpoint
•Alzheimer's Disease Assessment Scale - Cognitive Subscale
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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Clinical diagnosis of probable AD based on DSM-IV and the NINCDS-ADRDA criteria.
2. Male/female patient aged between 50 and 85.
3. mild to moderate probable AD :Middle school or above: 11 ≤MMSE ≤ 25, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16.
4. CT or MRI scan excluding another structural brain disease in one year.
5. Neurologic examination no significant abnormalities.
6. Hachinski Ischemic Score < 4;Hamilton Depression Scale ≤10. Able to complete the test procedure, audio-visual and physical ability to act to complete the neuropsychological measure.
7. Stable chaperone, more than 2 hours a day together with the patient or accumulated fewer than 14 hours per week.
8. Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study
Exclusion criteria
1. Proven or clinically suspected other type of dementia such as vascular dementia, Lewy body dementia, Parkinson's disease, frontotemporal dementia, g - Jakob disease (spastic pseudo-sclerosis), normal pressure hydrocephalus etc.
2. Sudden onset of early dementia or with gait disorders, seizures and behavioral changes.
3. Clinical manifestations of focal neurological signs (hemiparesis, sensory loss, visual field defect) or early extrapyramidal tract signs.
4. History of cerebrovascular disease and stroke.
5. Serious lack of folic acid and VitB12, syphilis antibody positive or thyroid dysfunction.
6. Mechanical intestinal obstruction patient ,Resting pulse less than 60,Severe liver or renal disease.
7. Patients with mechanical intestinal obstruction.
8. History of bone marrow transplantation.Mental illness, such as severe depression.
9. Cognitive damage caused by alcohol or drug abuse. Disable to correctly evaluate the cognitive function.
10. Critical condition, disable to make the exact evaluation of the efficacy and safety of new drug.
11. Use of any agent for the treatment of dementia within 4 weeks of randomization.
12. Be sensitive to ACHEI.
13. Be sensitive to two or more foods/drugs.
14. Use of another investigational agent within one months of screening.
Endpoints (4)
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
Function / daily living
1 endpointActivities of Daily Living:Activities of Daily Living Scale(ADL)
Time frame:20weeks
descriptive
Behavior / neuropsychiatric
1 endpointMental behavior: neuropsychiatric questionnaire (NPI)
Time frame:20weeks
Neuropsychiatric Inventory (NPI)
descriptive
Caregiver / quality of life
1 endpointClinician's Interview Based Impression of Change, plus caregiver input
Time frame:20weeks
descriptive
Other (unclassified)
1 endpointAlzheimer's Disease Assessment Scale - Cognitive Subscale
Time frame:20weeks
descriptive
Provenance
Sources
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.