Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers

ZhanYJ

Status: Enrolling

Conditions: Alzheimer Disease; Cognitive Impairment

Treatments: Other: Sham Acupuncture; Drug: Donepezil; Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06417086

23Y11921000

Details and patient eligibility

About

The goal of this clinical trial is to learn if acupuncture works to treat mild-to-moderate Alzheimer's disease, as well as the difference of its effect in APOE e4 carriers and non-carriers. It will also learn about the safety of acupuncture.

Researchers will compare acupuncture to a placebo (sham acupuncture) to see if acupuncture works to relieve the cognitive impairment and improve the ability of daily living and the quality of life. In addition, the plasma and neuroimaging biomarkers will be included as objective indexes.

Participants will:

Experience acupuncture or sham acupuncture 3 times per week for 12 weeks, and receive a 52-week follow-up.

Visit the clinic at Week 12, Week 38 and Week 64 for checkups and tests.

Full description

This is a two-centre randomized controlled trial. A total of 176 participants with mild-to-moderate Alzheimer's disease, 88 APOE e4 carriers and 88 non-carriers, will be randomly assigned to either an acupuncture combined with donepezil group or a sham acupuncture combined with donepezil group with a ratio of 1:1. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39. There will be 12 weeks of 3-session treatment for each participant, and a 52-week follow-up in total. The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at Week 12.

Enrollment: 176 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged between 50-85 years
• Diagnosed by the criteria of Neurological Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA)
• Cognitive impairment based on the scores of the Chinese version of the Mini Mental State Examination (MMSE) (patients with mild to moderate Alzheimers disease, 11≤primary school degree≤22, 11≤junior high school degree or above≤26
• Magnetic resonance imaging (MRI) confirmation of atrophy of the hippocampus or the medial temporal lobe volume, MRI manifestation of high possibility of Alzheimer Disease
• The Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score (≥2 for those under 75 years, and ≥3 for those over 75 years)
• Voluntarily joining this study with informed consents

Exclusion criteria

• Cognitive impairment caused by other factors (e.g. vascular dementia, dementia with Lewy bodies, frontotemporal dementia, hormone or metabolic abnormalities, hypothyroidism, folic acid or vitamin B12 deficiency, delirium or other mental and emotional disorders (such as schizophrenia and depression))
• A serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition
• Aphasia, disturbance of consciousness, or failure to cooperate with the related examinations due to physical disability
• Contraindications to undergoing an MRI scan such as claustrophobia or pacemaker implantation.
• Anticoagulant treatments such as warfarin or heparin
• Use of pacemakers or receiving acupuncture in the past 2 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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176 participants in 2 patient groups

Acupuncture Treatment

Experimental group

Description:

Participants in this group will receive acupuncture treatment in combination with donepezil for 12 weeks.

Treatment:

Other: Acupuncture

Drug: Donepezil

Sham Acupuncture Treatment

Active Comparator group

Description:

Participants in this group will receive sham acupuncture treatment in combination with donepezil for 12 weeks.

Treatment:

Drug: Donepezil

Other: Sham Acupuncture