Alzheimer disease
Conditions
Interventions
SCD Group (Part 1):no
MCI Group (Part 1):None
AD Group (Part 1):None
Trial group (Part 2):Dihuang Yizhi Formula
Common group (Part 2):Ginkgo Biloba
Sponsors
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: Part 1.(1) SCD: ? age 40~85 years; ? subjective memory decline, and self-reported cognitive concerns in the accepted scale test or confirmed by an informed person; ? normal neuropsychological scale and cognitive scale. (2) MCI: (1) Age 40-85 years; (2) Complaint of memory loss and confirmed by others, meeting the diagnostic criteria of MCI; (3) MMSE score of 24-30; (4) CDR-SB score of 0.5; (5) ADL score of <16; Haginsky Ischemia Scale score of =4; (6) Hamilton Depression Rating Scale score of =12. The score of Hamilton Depression Rating Scale was =12. (3) AD: mainly refer to the core clinical diagnostic criteria for likely AD dementia issued by the National Institute on Aging and the Alzheimer's Disease Society (2011): ? Establishing the Dementia Diagnostic Simple Mental State Examination Scale (MMSE) based on clinical examination, with a score of = 26 for university education, = 23 for less than secondary education, and=22 for illiteracy; ? At least two or more impairments in cognitive function ? persistent deterioration of other cognitive functions of memory; ? no impairment of consciousness; ?ability to perform daily living scale=16 points; ?no significant cerebrovascular disease: HIS<7 points; ?no physical disease or other brain diseases that can cause progressive deficits in memory and cognition; ?sufficient hearing and visual acuity to cooperate with clinical studies, as well as a certain level of literacy, previous ability to read simple texts and write simple sentences. Part 2. ? Patients with complaints of memory loss and confirmed memory difficulties by others, meeting the diagnostic criteria of MCI in Western medicine; ?meeting the identification criteria of Chinese medicine for kidney essence deficiency with phlegm and stagnation; ?patients aged 40-85 years; ? Simple Mental State Examination (MMSE) scores of 24-30; ?Clinical Dementia Rating Scale-Total Score (CDR-SB) scores of 0.5; ?Daily living ability scale scores < 16; ?Haikinsky Ischemia Scale score =4; ?Hamilton Depression Rating Scale score =12; ?Patients who had signed the informed consent form.
Exclusion criteria
Exclusion criteria: Part 1.? clear history of stroke; ?major depression (HAMD > 24); ?cognitive impairment due to traumatic brain trauma; ?other neurological disorders associated with cognitive impairment, such as brain tumors, Parkinson's disease, encephalitis and epilepsy; ?other systemic disorders that can cause cognitive impairment, such as thyroid dysfunction, severe anemia, syphilis and AIDS; ?history of psychiatric disorders or congenital mental retardation; ?inability to cooperate with study procedures. Part 2.? Definite dementia: MMSE = 24 points or meeting DSM-IV dementia diagnostic criteria; ? Significant cerebrovascular disease: HIS > 4 points or clinical cerebral infarction; ? Moderate depression or another psychiatric disorder within the past 2 years meeting DSM-IV criteria; ? History of alcohol or drug abuse or addiction within the past 2 years (DSM-IV criteria); ? History of schizophrenia (DSM-IV criteria) ); ? any significant neurological disease such as Parkinson's disease, Huntington's disease, normal cranial pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, history of severe head trauma with persistent neurological deficits or known structural brain abnormalities; and ? inability to cooperate with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chinese medical syndrome(Part 1);brain function connectivity characteristics (Part 1);MMSE(Part 2);MoCA(Part 2);ADAS-cog(Part 2);Functional brain connectivity characteristics(Part 2); | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM Clinical Symptom Score(Part 2);ADL(Part 2); | — |
Countries
China
Contacts
Public ContactAn Hongmei
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed