MedPath

Therapeutic Effect of 'tonify kidney and replenish essence prescription' on Alzheimer's Disease

Phase 1
Conditions
Alzheimer's Disease
Registration Number
ITMCTR1900002790
Lead Sponsor
Ruijin Hospital affiliated toShanghai Jiao Tong University School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Aged 50-70 years;
2. Medication status: did not systematically take anti-dementia and cognitive improvement drugs;
3. Clinica Dementia Rating (CDR) (0.5 < CDR<=1), mild AD meets the nia-aa diagnostic criteria:
(1) hinders work or daily activities;
(2) Life function and executive ability decline than the previous level;
(3) cannot be explained by delirium or other serious mental disorder;
(4) cognitive impairment through the combination of medical history collection and objective cognitive evaluation to find and diagnose;
(5) cognitive or behavioral impairment includes at least the following two aspects: be able to learn and remember new information; reasoning and judgment in handling complex tasks; visual spatial ability; language functions (speaking, reading, writing); changes in personality or behavior. And the following characteristics possess at the same time: 1.a clear history of cognitive deterioration reported or observed;
(6) the initial and major cognitive impairment found during the history and physical examination falls into the following categories: amnestic manifestations; Non-amnestic manifestations which include language impairment, visuospatial impairment, or executive dysfunction;
4. Each subject shall have a stable and reliable caregiver who can accompany the subject when necessary for examination or treatment.

Exclusion Criteria

1. Cognitive decline secondary to other reasons: neurovascular disease, infection in central nervous system, Creutzfeldt-Jakob disease, Huntington's disease and Parkinson s disease, dementia with Lewy body, traumatic dementia, physical and chemical factors (drug, alcohol, carbon monoxide and etc.), somatic diseases (hepatic encephalopathy, pulmonary encephalopathy and etc.), intracranial occupative disorders (subdural hematoma and brain tumor), endocrine disease (thyroid disorders and parathyroid disorders), and dementia due to vitamin deficiency or other reasons.;
2. used to be diagnosed as neurological disorders, including stroke, ophthalmoneuromyelitis, Parkinsons disease, epilepsy and etc.;
3. used to be used to be diagnosed as psychiatric disorders, including schizophrenia or other mental disorder (diagnose according to DSM-IV criteria), bipolar disorder, severe depression or delirium;
4. if the subject could cooperate to finish scales or other assessments due to uncorrectable visual and auditory impairment;
5. when research fellow dont think the subject could persist during the whole research.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Cognition rating scales;
Secondary Outcome Measures
NameTimeMethod
Amyloid-beta PET;
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