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Clinical trial for the behavioral and Imaging study of Dengzhan Shengmai Capsule on amnestic mild cognitive impairmen

Clinical Trial for the Behavioral and Imaging study of Dengzhan Shengmai Capsule on amnestic mild cognitive impairment

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011556
Enrollment
Unknown
Registered
2017-06-02
Start date
2017-06-02
Completion date
Unknown
Last updated
2017-06-05

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

Conditions

amnestic mild cognitive impairment

Interventions

Dengzhan Shengmai Capsule group:Basic treatment and Dengzhan Shengmai Capsule
Placebo control group:Basic treatment and placebo Capsule

Sponsors

Centre for Beijing Aging Brain Rejuvenation initiative, Beijing Normal University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Aged between 50 to 80 years; 2) Education level > 6 years; 3) aMCI diagnosis in line with Petersen diagnostic criteria; 4) normal daily basic functions Complex instrumental routine functions can be slightly damaged; 5) No dementia; 6) 18F-AV45 PET imaging showed Aß deposition was positive or nuclear magnetic resonance imaging showed hippocampal atrophy; 7) subjects or legal guardian sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) transient ischemic attack (TIA); 2) cerebral hemorrhage or subarachnoid hemorrhage; 3) confirmed by the brain tumor, brain trauma, blood disease caused by stroke subjects; 4) due to rheumatic heart disease, coronary heart disease and other heart disease with atrial fibrillation, caused by cerebral embolism; 5) combined with liver, kidney, hematopoietic system, endocrine system and other serious diseases and bone and joint disease; 6) mental disorders or severe dementia; 7) subjects undergoing cardiac pacemaker surgery, coronary intervention, and coronary artery bypass surgery, who were not eligible for MRI; 8) Subjects who have magnetic intra-articular implants and who can not undergo magnetic resonance imaging; 9) Allergy to this test drug; 10) taking drugs to improve brain function (such as cholinase inhibitors) and so on.

Design outcomes

Primary

MeasureTime frame
Alzheimer's disease assessment scale, ADAS-cog;Auditory Verbal Learning Test, AVLT;activate value of brain region in resting state;Network value of white matter fiber tracts;Aß protein deposition of brain tissue (SUV);glucose metabolism of brain tissue;blood coagulation;

Secondary

MeasureTime frame
Mini-Mental Status Examination, MMSE;Montreal Cognitive Assessment scale, MoCA;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;

Countries

China

Contacts

Public ContactZhanJun ZHANG

Centre for Beijing Aging Brain Rejuvenation initiative, Beijing Normal University

zhang_rzs@bnu.edu.cn+86 010 58802005

Outcome results

None listed

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