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Randomized, Double-Blind, Multicenter Clinical Study on Piperazine Ferulate Tablets in the Treatment of Mild to Moderate Alzheimer's Disease

Randomized, Double-Blind, Multicenter Clinical Study on Piperazine Ferulate Tablets in the Treatment of Mild to Moderate Alzheimer's Disease - RCT of Piperazine Ferulate tablets on mild to moderate of AD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087704
Enrollment
Unknown
Registered
2024-08-01
Start date
2024-10-24
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Alzheimers disease

Interventions

Piperazine Ferulate tablet Group:Piperazine Ferulate tablet, 2 tablets (200mg) tid, 3 months
Placebo Group:Placebo tablet, 2 tablets (200mg) tid, 3 months

Sponsors

Luohu District People's Hospital, Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Between 55-85 years old; 2. No gender limit; 3. With memory decline as the first symptom, it meets the diagnosis criteria of China Alzheimer's dementia Treatment Guidelines (2020 edition) of China Elderly Care Association in 2021, and was clinically diagnosed as mild to moderate Alzheimer's disease (MMSE10 to 26); 4. Completion: head MRI + MRA; APOE genotype; blood routine, liver function, renal function, fasting blood glucose, glycated hemoglobin, lipids, homocysteine, serum vitamin B12, folic acid, A, and antibody 2 items, syphilis and HIV testing. 5. If there is hypertension, diabetes, heart disease, the disease should be stable; 6. After the detection of CSF AD markers or blood AD markers to support the diagnosis of Alzheimer's disease, the baseline level (CT or MRI) remains relatively consistent; 7. Ability to match MMSE score, ADL score, NPI score, ADAS-Cog scale and CDR-SB scale; 8. Living in guangdong for more than half a year, with stable caregivers, can ensure follow-up.

Exclusion criteria

Exclusion criteria: 1.Excluding frontotemporal dementia with personality, personality and language changes as the first symptoms; 2. Lewy body dementia and Parkinson's disease dementia associated with symptomatic fluctuations, vivid visual hallucinations, bradykinesia; 3.Clinical suspicion of progressive suprpranuclear palsy dementia, cerebrovascular disease dementia, normal skull pressure hydrocephalus dementia; 4. Head CT or MRI diagnosis confirmed except for acute cerebrovascular disease; 5. Cerebrovascular accidents occurred within 3 months before enrollment. 6. Excluding other treatment measures, such as exercise rehabilitation physiotherapy intervention. 7.Past medical history included diabetes, hypertension and cerebrovascular disease, moderate to severe anemia and other hematological malignancies, thyroid disease, heart disease, malignancy, severe respiratory and digestive diseases, and liver and kidney insufficiency. 8.Using cholinesterase inhibitors, memantine, cytocholine sodium capsule, Ginkgo biloba leaf extract tablet, neyergolin, dihydroergoline sustained release tablet, Oracetam capsule, manute sodium capsule, Chinese patent medicine including nourishing serum brain granule, Dengzhan Shengmai capsule, Huatuo reengineering pill, Tianzhi granule, etc.;

Design outcomes

Primary

MeasureTime frame
Mini-mental state examination score;Activity of Daily Living Scale;Neuropsychiatric Inventory Score;Alzheimer’s Disease Assessment Scale-Cognitive section, ADAS-Cog;CDR-SB Score;Liver and kidney function tests;

Secondary

MeasureTime frame
Serum biomarkers of AD including Aß42, Aß40, GFAP, NFL and p-Tau 181;Serum imflammatory factors including Hypersensitive C-reactive protein, TNF- a, and IL-6;

Countries

China

Contacts

Public ContactFeiqi Zhu

Luohu District People's Hospital, Shenzhen

zfqzsu2004@aun.com+86 138 2870 9589

Outcome results

None listed

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