Alzheimer
Conditions
Interventions
single arm:Traditional Chinese Medicine Zhishan Formula Base Formula/AI Optimization Formula
Sponsors
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Meets the NIA-AA (2011) core clinical criteria for AD dementia (A, B, C, D); A. Hidden onset. Symptoms gradually occur over several months or years, rather than suddenly occurring for a few hours or days; B. Report or observe a clear history of cognitive deterioration; C. Early and most prominent cognitive impairment confirmed by medical history and examination can be classified into one of the following categories: (a) Oblivion symptoms: This is the most common manifestation of AD dementia, including impairments in learning and recalling recently acquired information, as well as evidence of cognitive impairment in at least one other cognitive domain. (b) Non forgetting symptoms: (1) Language disorders: The most prominent impairment is difficulty finding words, and there should also be other cognitive impairments. (2) Visual spatial impairment: The most prominent impairment is spatial cognitive impairment, including object recognition, face recognition, visual image combination recognition, and misreading, as well as other cognitive domain impairments. (3) Executive dysfunction: The most prominent impairments are impairments in reasoning, judgment, and problem-solving, and there should also be impairments in other cognitive domains. D. Exclusion criteria (situations that should not be diagnosed as pro AD dementia): (a) Accompanied by substantial cerebrovascular disease, determined by a history of stroke related to the onset or worsening of cognitive impairment; Or there may be multiple or widespread infarctions or severe white matter hyperintensities; or (b) Core features of DLB other than dementia itself; or (c) The prominent features of bvFTD; or (d) The prominent features of svPPA or nfvPPA/avPPA; or (e) Another concurrent, active neurological disorder or another concurrent non neurological complication, or the use of drugs that may have a significant impact on cognition. (2) Weight between 45-90kg; (3) Age range of 65-85 years old (including 65 and 85 years old), male or female not limited; (4) The severity of dementia is mild to moderate (baseline dementia severity is determined by MMSE score of 15-26 points, and baseline dementia diagnosis is based on MMSE education adjustment values: university = 26 points, middle school = 24 points, primary school = 23 points, illiteracy = 22 points); (5) The visual score scale for medial temporal atrophy (MTA) on coronal head MRI scan is = 1.5 points (adjusted for age: 55-64 years = 1.0 points, 65-74 years = 1.5 points, 75-85 years = 2.0 points); (6) Stable drug use: If currently receiving approved Alzheimer's disease (AD) treatment, such as cholinesterase inhibitors (AChEIs) or Memantine, or both, dosage stability must be maintained for at least 4 weeks prior to baseline. Subjects who have not received AD treatment can also participate in the study. (7) The patient has sufficient vision and hearing to participate in clinical evaluation; (8) Can read simple articles and write simple sentences; (9) Having stable caregivers; (10) Informed consent, signed by the individual or guardian.
Exclusion criteria
Exclusion criteria: (1)Severe AD dementia (MMSE 14-0); (2) Non AD dementia, including vascular dementia, frontotemporal dementia, Parkinson's disease dementia, Lewy body dementia, Huntington's disease, subdural hematoma, communicating hydrocephalus, brain tumors, thyroid disease, vitamin deficiency or other diseases that may cause cognitive impairment, or severe brain infections (including neurosyphilis, meningitis or encephalitis), etc; (3) Unstable mental disorders exist, including severe depression (HAMD = 17), severe anxiety disorder (HAMA = 12), bipolar disorder, schizophrenia, etc; (4) History of alcohol or drug abuse in the past 5 years; (5) Those who have received drugs that affect the central nervous system, such as antidepressants, benzodiazepines, etc., but have a stable dose for less than 4 weeks (but those who have a stable dose for = 4 weeks can be enrolled) (6) History of allergies to any component of traditional Chinese medicine; (7) Individuals who have received treatment with A ß monoclonal antibodies within the past year; (8) Participate in other clinical studies within the past 30 days; (9) The investigators believe that there are other circumstances that are not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer disease assessment scale-cog; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comprehensive cognition: Mini Mental State Examination (MMSE);;Execution Function: Connection Test Group B (TMT-B);Visual Space Function: Clock Drawing Test (CDT);;Language Function: Boston Naming Test (BNT);Life skills: Activities of Daily Living (ADL);;Exploration of target syndromes: Dementia Syndrome Typing Scale (PES-D);;Exploratory Indicators: Plasma Aß40, Aß42, T-tau, P-tau181, P-tau217, NfL, GFAP;;Peripheral blood signaling pathway (dual omics of plasma proteome and PBMC transcriptome); | — |
Countries
China
Contacts
Public ContactShi Jing
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Outcome results
None listed