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Clinical Trial for the Behavioral and Imaging Study of Shen Qi Yi Zhi Formula Granules Intervenes in Alzheimer's Disease

Clinical Trial for the Behavioral and Imaging Study of Shen Qi Yi Zhi Formula Granules Intervenes in Alzheimer's Disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-14005373
Enrollment
Unknown
Registered
2014-10-20
Start date
2014-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Alzheimer’s disease

Interventions

Group A:Shen Qi Yi Zhi Formula Granules
Group B:Donepezil

Sponsors

Centre for Beijing Aging Brain Rejuvenation Initiative, Beijing Normal Univrsity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: (The following 5 items are required to comply with): (1) Accord with diagnostic criteria of probable AD in NINCDS-ADRDA; (2) Mild or moderate dementia, MMSE score more than 10 and less than 24; (3) Aged between 50 to 80 years; (4) The patient or their legal representative signed the informed consent; (5) Good compliance.

Exclusion criteria

Exclusion criteria: (Subjects would be exclusive when complied any of the item following) (1) Not accord with diagnostic criteria of AD, or dementia caused by other reasons; (2) Vascular dementia or geriatric depressive; (3) Allergic constitution or be allergic to various drugs; (4) Mental disorders or severe dementia; (5) Bone and joint diseases and some other serious diseases which were associated with liver, kidney, hematopoietic system and endocrine system etc; (6) Cognitive impairment caused by head trauma; (7) With disease that may disturb cognitive evaluation, include hard-drinking, drug abuse or other mental medicine abuse; (8) Severe neurologic defect; (9) Patients can not be performed with MRI which has accepted pacemaker surgery, coronary intervention surgery or coronary artery bypass surgery; (10) Patients can not be performed with MRI which has a magnetic implant inside.

Design outcomes

Primary

MeasureTime frame
Mini-Mental State Examination (MMSE);Auditory Verbal Learning Test (AVLT);

Secondary

MeasureTime frame
Montreal cognitive assessment (MoCA);Symbol Digit Modalities Test (SDMT);Boston Naming Test (BNT);Digit Span Test;Clock Drawing Test (CDT);Stroop Color-word Test;Trail Making Test (TMT);Activity of Daily living (ADL);

Countries

China

Contacts

Public ContactZHANG Zhan-Jun
zhang_rzs@bnu.edu.cn+86 010 58802005

Outcome results

None listed

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