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A randomized, double-blind, placebo-controlled, multicenter clinical Trial for anthocyanin complex preparations for Mild-to-Moderate Alzheimer's disease

A randomized, double-blind, placebo-controlled, multicenter clinical Trial for anthocyanin complex preparations for Mild-to-Moderate Alzheimer's disease

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025869
Enrollment
Unknown
Registered
2019-09-12
Start date
2019-01-01
Completion date
Unknown
Last updated
2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer’s disease

Interventions

Placebo group:Placebo
Experimental group:anthocyanin complex preparations

Sponsors

Aerospace Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 50 to 85 years; 2. Mild-to-Moderate AD, i.e.the MMSE score 11-26; 3. Meeting the diagnostic criteria for AD by the NINCDS-ADRDA(1984); 4. Sufficient visual and auditory resolution acceptable neuropsychological tests; 5. There is a certain level of education, read simple texts and write simple sentences; 6. A stable caregiver; 7. Single therapy was initiated on memantine during the tresearch periodand the patient was agreed that the treatment of memantine remained unchanged for three months during the study; 8. Signed the inform consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have dementia caused by other factors: including VaD, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, chronic subdural hematoma and multiple sclerosis, severe head trauma with persistent neurological deficits or abnormal brain structure known; 2. Patients who have suffered from cerebrovascular disease, thyroid disease, vitamin B12 or folate deficiency, anemia or severe malnutrition, severe heart, liver, lung, kidney and other organ disease affecting the central nervous system dysfunction; cerebral vascular disease where the evidence in single or multiple vascular territories, and cognitive decline associated with brain infarction important parts, including the angular gyrus, thalamus, basal forebrain, the anterior cerebral artery territory back to the brain, multiple basal ganglia infarcts, white matter ischemic changes involving extensive white matter region least a full 25% or more; 3. Allergies , Aricept or hydrochloric acid piperidine derivatives allergy; 4. Taking cholinergic or anticholinergic drugs and drugs that affect cognitive function at the same period; 5. Patients who have suffered from depression, schizophrenia and other mental illness; 6. Alcohol, long-term use of antipsychotics; 7. Patients who can not coordinate with cognitive function tests.

Design outcomes

Primary

MeasureTime frame
cognitive ability;Activities of daily living;Mentality;MoCA;

Secondary

MeasureTime frame
Clinical Global Impression (CGI);

Countries

China

Contacts

Public ContactWang Peifu

Aerospace Central Hospital

whongquan@alu.fudan.edu.cn+86 13611106725

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026