Alzheimer's disease
Conditions
Interventions
Control:Donepezil 5mg is taken orally every evening in combination with placebo, which is taken orally three times a day with a dosage of 300mg per administration.
High-dose combination therapy group:Donepezil 5mg is taken orally every evening in combination with phosphatidylcholine capsules, which are taken orally three times a day with a dosage of 300mg per ad
Low-dose combination therapy group:Donepezil 5mg is taken orally every evening in combination with placebo, which is taken orally three times a day with a dosage of 100mg per administration, and phosp
Cohort of MCI,AD,DLB,FTD,VaD:NA
Sponsors
Shandong First Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for clinical cohort construction of Alzheimer's disease and other dementias: ?Age = 50 and = 85 years. ?Meet the diagnostic criteria for dementia or MCI. ?Neurocognitive assessment scores: 11 = MMSE = 28, CDR = 2. ?Patients and their family members are informed and sign an informed consent form. Inclusion criteria for drug interventions: ?Age = 50 and = 85 years old; ? Complies with the 2011 NIA-AA AD diagnostic criteria; ? Patients with mild to moderate illness have a neuropsychological score of 11 points = MMSE = 24 points, 0.5 = CDR = 1 point; ? The total score of the improved HACHINSKI ischemic score (m-HIS) is less than 4 points; ? Hamilton Depression Scale (24 item version) with a total score of = 20 points; ? Head MRI plain scan during screening period: showing the highest possibility of AD (with hippocampal atrophy); If the patient can provide a head MRI film that meets the requirements of the protocol within 3 months before screening, it can be used as a screening basis and does not need to be repeated; If the inclusion criteria for drug intervention are met, the skull MRI that meets the protocol requirements still needs to be rescanned during the baseline period; ? There were no obvious positive signs in the nervous system examination; ? The subjects should have stable and reliable caregivers, or at least have frequent contact with caregivers (at least 3 days per week and at least 2 hours per day), who will assist the patients in participating in the entire study process. Caregivers must accompany the subjects during research visits and assist them in completing scales such as NPI and ADCS-ADL23. ? Patients and their families are informed and sign informed consent forms.
Exclusion criteria
Exclusion criteria: Exclusion criteria for clinical cohort construction of Alzheimer's disease and other dementia: ?Presence of other neurological diseases that can cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, normal pressure hydrocephalus, etc.). ?Presence of other systemic diseases that can cause cognitive impairment (such as liver failure, renal failure, abnormal thyroid function, severe anemia, folate or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.). ?Suffering from diseases that prevent cooperation in completing cognitive assessments. ?Presence of contraindications for magnetic resonance imaging (MRI). ?Presence of mental and neurological developmental delays. ?Refusal to undergo blood tests. ?Refusal to sign an informed consent form. Exclusion criteria for drug interventions: ? Other neurological diseases that can cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, normal intracranial pressure hydrocephalus, etc.); ? Other systemic diseases that can cause cognitive impairment (such as liver dysfunction, kidney dysfunction, thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.); If blood test data from patients within the first half month of screening can be obtained, it can be used as a screening basis and does not need to be collected repeatedly; If the researcher is unable to determine whether the subject's condition has changed, additional pre enrollment blood tests can be added; ? Suffering from diseases that cannot cooperate in completing cognitive tests; ? There are contraindications to magnetic resonance imaging; ? Existence of mental and neurological developmental delays; ? Refuse to draw blood; ? MRI examination showed significant focal lesions, with one of the following: a>2 infarcted lesions with a diameter greater than 2cm, or mHIS total score = 4; b. Key areas such as the thalamus, hippocampus, entorhinal cortex, paraolfactory cortex, angular gyrus, cortex, and other subcortical gray matter nuclei in infarcted areas; c. Fazekas Scale grading of white matter damage = 3; ? There are abnormal laboratory indicators: liver function (ALT, AST), renal function (Cr), creatine kinase exceeding the upper limit of the normal range by 2 times; ? Participants in clinical research on other drugs; ? Within one month prior to the start of this study, other medications that affect cognitive function were used, such as memantine, cholinergic drugs, antipsychotic drugs, anxiolytics, and cognitive enhancers; ? Individuals who are allergic to donepezil or citicoline capsules or have a history of adverse reactions; ? Researchers believe that participants are not suitable for the experiment; ? Refusing to sign informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-cog score; | — |
Secondary
| Measure | Time frame |
|---|---|
| ADAS-Cog11 score;Score of MMSE, MoCA, CDR, NPI, ADCS-ADL23;Brain MRI Whole Brain Gray Matter Volume;Ventricular volume;Hippocampal volume;Cortical thickness;Biomarkers including blood and cerebrospinal fluid Aß 42, T-tau, p-tau proteins; | — |
Countries
China
Contacts
Public ContactYifeng Du
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Outcome results
None listed