Alzheimers disease
Conditions
Interventions
Experimental drug set:Cistanche total glycoside capsules orally 2 capsules at a time 3 times a day
Placebo group:Cistanche total glycosides capsule simulator, orally, 2 capsules at a time, 3 times a day
Sponsors
Shanghai Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Meet the core clinical diagnostic criteria for probable AD from the National Institute on Aging and the Alzheimer's Association (NIA-AA) (2018); (2) For patients with mild or moderate disease 11 points =MMSE total score =24 points (if the subject has primary school education 11 points =MMSE total score =22 points); If the MMSE score increased or decreased by more than 2 points compared with the baseline period and screening period participants must discuss with the magnetic resonance imaging (MRI) diagnostic review panel if they want to continue to participate in the study. To exclude subjects who have difficulty distinguishing the efficacy of a drug as well as enrolled patients with possible diagnostic errors; (3) Clinical Dementia Rating Scale (CDR) score of 1 or 2; (4) TCM syndrome differentiation belongs to deficiency of the sea of marrow; (5) Age 50-85 years old (including both ends) gender is not limited; (6) Primary school education or above and the ability to complete the cognitive ability tests and other tests prescribed by the program; (7) Memory loss for at least 12 months with a progressive worsening trend; (8) Hamilton Depression Scale / 17-item (HAMD) total score =10; (9) The total score of Huggins Ischemia Scale (HIS) was =4 points; (10) lesions of less than 25% of total white matter (Fazeca scale for WM lesions =1 lesions of mild lesions) and less than or equal to 2 lacunar lesions with a diameter greater than 1.5cm were detected during screening. The absence of luminal foci in key areas such as the thalamus hippocampus entorhinal cortex parolhinal cortex cortex and subcortical gray matter mass had the highest likelihood of showing Alzheimer's disease on MRI (MTA-score=2). (11) There were no obvious positive signs in nervous system examination; (12) Subjects should have a stable and reliable caregiver or at least frequent contact with the caregiver (at least 4 days a week at least 2 hours a day) who will assist the patient throughout the study. The caregiver must accompany the subject to the study visit and must have sufficient interaction and communication with the patient to provide valuable information for NPI ADCS-ADL CIBIC-PLUS CDR and other scales. (13) The subject must sign a written informed consent before performing any operation or examination related to the protocol. If the subject is unable to sign due to limited cognitive ability the subject's signature is allowed to be left blank and the reason is stated. The legal guardian shall sign the reason statement and the legal guardian shall sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Dementia caused by other causes: vascular dementia central nervous system infection (such as AIDS syphilis etc.) Creutzfeldt-Jakob disease Huntington's disease and Parkinson's disease lewy body dementia frontotemporal degeneration traumatic brain dementia other physical and chemical factors (such as: Drug poisoning alcoholism carbon monoxide poisoning etc.) important physical diseases (such as hepatic encephalopathy pulmonary encephalopathy dialysis encephalopathy hypoxic encephalopathy encephalitis brain trauma etc.) intracranial space occupying lesions (such as: Subdural hematoma communicating hydrocephalus brain tumor) endocrine system disorders (such as thyroid disease parathyroid disease) and dementia caused by vitamin or other element deficiencies; (2) Patients with other diseases with lesions indicating non-AD on imaging (such as large cerebral infarction critical site cerebral infarction multiple lacunar cerebral infarction moderate to severe white matter lesions cerebral hemorrhage hydrocephalus etc.); (3) Persons with mental illness according to DSM-V criteria including schizophrenia or other mental illness bipolar disorder major depression or delirium; (4) Have suffered from neurological diseases (including stroke optic neuromyelitis Parkinson's disease epilepsy etc.); (5) Abnormal laboratory indicators: Hepatitis B two-and-a-half indicators Hepatitis B surface antigen HBs Ag and hepatitis Be antigen HBe Ag and/or hepatitis B core antibody Hbc Ab positive hepatitis is active liver function (ALT AST) is 1.2 times higher than the upper limit of the normal range serum creatinine (Cr) is 1.2 times higher than the upper limit of the normal range The white blood cell count platelet and hemoglobin were lower than the lower limit of the normal range in the laboratory of the research center and the fasting blood glucose value was more than 1.2 times the upper limit of the normal range. (6) Uncontrolled hypertension: systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg; (7) Unstable or severe heart lung liver kidney and hematopoietic system diseases (including unstable angina pectoris myocardial infarction uncontrolled asthma active gastric bleeding cancer mechanical intestinal obstruction bone marrow transplant history etc.); Resting heart rate < 55 beats/min after 10 minutes of rest QTc (QTc B (Bazett's correction) or QTc F (Fridericia's correction)) =450msec (QTc=480msec for patients with bundle branch block and assisted by a specialist) There were ECG abnormalities that the investigators judged unsuitable for inclusion; (8) The presence of visual and hearing disorders can not complete the neuropsychological test and scale assessment; (9) Alcohol or drug abusers; (10) people who are currently using Alzheimer's disease treatment drugs that cannot be discontinued; (11) Allergies such as allergies to two or more drugs or foods or known allergies to the ingredients contained in the drugs used in this study; (12) Have participated in other clinical trials (excluding non-drug intervention clinical studies) within 30 days before the screening visit for this study or plan to participate in other clinical trials during the study period; (13) women who are pregnant breastfeeding or planning a pregnancy or women who are fertile and not using highly effective contraception; (14) For any reason the investigator considers it impossible for the subject to complete the study; (15) The subject is a direct relative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the score of the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog/11) compared to the baseline after medication administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Alzheimer's disease Quality of Life Assessment Scale (QOL-AD) scores from baseline after medication;Change of clinical Visiting Impression Scale (CIBIC-plus) score from baseline;Changes in neuropsychiatric scale (NPI) scores from baseline after medication;Changes from baseline in the post-medication Alzheimer's Disease Collaborative Study-Ability of Daily Living Scale (ADCS-ADL) score;Changes in Clinical Dementia Rating Scale (CDR-SB) scores from baseline;Changes of TCM syndrome score from baseline after medication; | — |
Countries
China
Contacts
Public Contactliwentao
Shanghai Hospital of Traditional Chinese Medicine
Outcome results
None listed