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The intervention effect of Shenqi Yizhi Keli on preclinical Alzheimer Disease: a randomized controlled trial

The intervention effect of Shenqi Yizhi Keli on preclinical Alzheimer Disease: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053125
Enrollment
Unknown
Registered
2021-11-12
Start date
2020-01-01
Completion date
Unknown
Last updated
2022-09-06

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

Conditions

Preclinical Alzheimer Disease

Interventions

Experimental Group:Shenqiyizhi Keli, Pro, Bid
Control Group:Aricept (donepezil hydrochloride), Pro, Qd

Sponsors

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Outpatients or inpatients aged 50-80 years and community elderly population, regardless of gender, education level >= 6 years; 2. Determined cognitive impairment based on neuropsychological scale and clinical symptoms (at least one cognitive field score below 1.0SD); 3. Meet the NIA-AA preclinical Alzheimer Disease diagnostic criteria.

Exclusion criteria

Exclusion criteria: 1. Participants with severe caridiac, liver, and kidney dysfunction; 2. Participants with other mental and neurological disorders and malignant tumors; 3. The Geriatric Depression Scale (GDS) score <10 points, excluding cognitive impairment due to emotions; 4. Those who have participated or are participating in other drug trials within three months before being selected; 5. Poor compliance, severe illness or being dying as well as expected survival time is less than 1 year, who cannot complete the course of treatment; 6. Use other cognitive-improving drugs such as ChEIs or other psychotropic drugs within the past three months; 7. MRI contraindications.

Design outcomes

Primary

MeasureTime frame
Alzheimer's disease assessment scale, ADAS-cog;Auditory Verbal Learning Test, AVLT;Mini-Mental Status Examination, MMSE;

Secondary

MeasureTime frame
Rey-Osterrich Complex Figure Test;Activity of daily living;Trail Making Test;Clock Drawing Test;Symbol Digit Modalities Test;Verbal Fluency Test;Boston Naming Test;Network value of white matter fiber tracts;

Countries

China

Contacts

Public ContactLi He

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine

her2003@163.com+86 13811595059

Outcome results

None listed

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