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UnknownPhase 2

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

Asset

Octohydroaminoacridine succinate

Listed sites

13

Recruiting sites

13

Enrollment

288

estimated

Study population

Alzheimer’s disease

Key I/E criteria

Alzheimer's diseaseMMSE ≤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

Org study IDCCHY2010L00161-HPAD2
NCT IDNCT01569516

Timeline

Milestones

Study start2011-06 (month precision)
Study first posted2012-04-03estimated
Last update posted2012-04-09estimated
Primary completion2012-07estimated (month precision)
Study completion2012-10estimated (month precision)

Assets

Drug assets

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

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
Behavior / neuropsychiatric
1
Caregiver / quality of life
1
Other (unclassified)
1

Function / daily living

1 endpoint
Secondary/protocol endpoint

Activities of Daily Living:Activities of Daily Living Scale(ADL)

Time frame:20weeks

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Mental behavior: neuropsychiatric questionnaire (NPI)

Time frame:20weeks

Neuropsychiatric Inventory (NPI)

descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Clinician's Interview Based Impression of Change, plus caregiver input

Time frame:20weeks

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Alzheimer's Disease Assessment Scale - Cognitive Subscale

Time frame:20weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.