Alzheimers disease
Conditions
Interventions
sham acupuncture group:Donepezil hydrochloride oral combined with Cognitive Behavioral Therapy for Insomnia (CBT-I) and Sham Acupuncture
Mind-tranquilizing Acupuncture group:Donepezil hydrochloride oral combined with Cognitive Behavioral Therapy for Insomnia (CBT-I) and Mind-tranquilizing Acupuncture treatment
control group:Donepezil hydrochloride oral combined with Cognitive Behavioral Therapy for Insomnia (CBT-I)
Sponsors
Nanchang Hongdu Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1)Diagnosis of Alzheimer's Disease (AD): All participants meet the diagnostic criteria for Alzheimer's disease dementia as outlined in the Guidelines for the Diagnosis and Treatment of Alzheimer's Disease Dementia in China (2020 Edition) and the NIA-AA Core Clinical Criteria for AD Dementia. The diagnosis is supported by neuroimaging (cranial CT/MRI). Participants have a Clinical Dementia Rating (CDR) score of 1.0 (mild) or 2.0 (moderate), indicating mild-to-moderate AD dementia. (2)Diagnosis of Sleep Disorders (SD): Participants meet the diagnostic criteria for "Chronic Insomnia Disorder" as defined in the Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults (2023 Edition) and the International Classification of Sleep Disorders, 3rd Edition (ICSD-3). Participants must have an Insomnia Severity Index (ISI) score ranging from 8 to 21 (8 = ISI = 21), indicating mild-to-moderate sleep disorders. (3)Demographics: Aged=65 years, any gender. Participants must have = 6 years of education (primary school graduation or higher). (4)Contraindications: No known allergies or contraindications to the investigational medication/study drug. (5)Informed Consent: Both the participants and their family members (or legal guardians) are fully informed about the study and have voluntarily signed the Informed Consent Form (ICF). (6)Compliance: Participants are capable of completing the treatment regimen and follow-up visits.
Exclusion criteria
Exclusion criteria: (1)Non-AD Dementia: Patients with vascular dementia or secondary dementia caused by other etiologies. (2)Medication Interference: Patients who have taken psychotropic medications within 1 month prior to the study, or sedative-hypnotic medications within 1 week prior to screening. (3)Other Sleep Disorders: Patients with sleep-related breathing disorders, circadian rhythm sleep-wake disorders, or other sleep dysfunctions. (4)Secondary or Lifestyle-Induced Insomnia: Insomnia induced by drugs (e.g., substance abuse or medication side effects); sleep disorders caused by poor lifestyle habits (e.g., alcohol consumption, drinking coffee in the evening, or drinking strong tea before bedtime); or secondary insomnia clearly caused by other mental disorders. (5)Comorbidities: Presence of liver or kidney dysfunction, tumors, psychiatric diseases, or severe diseases of the cardiovascular, cerebrovascular, respiratory, or digestive systems. (6)Inability to Cooperate: Patients with severe neurological deficits (e.g., aphasia, agnosia) that prevent cooperation with testing and evaluation. (7)Skin Conditions or Prior Therapy: Severe skin infection at the site of medication application or acupoints; or receipt of acupuncture intervention within the past 3 months. (8)Psychiatric History: History of severe psychiatric disorders, such as schizophrenia or bipolar disorder. (9)Severe Depression/Anxiety: Patients with severe depression or severe anxiety, defined as a Hamilton Depression Rating Scale (HAMD-17) total score = 24, or a Hamilton Anxiety Rating Scale (HAMA) total score > 28.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale;Brief Mental State Examination;Alzheimer's Disease Quality of Life Scale; | — |
Countries
China
Contacts
Public ContactLiuhang
Nanchang Hongdu Hospital of Traditional Chinese Medicine
Outcome results
None listed