Evaluating acupuncture for Alzheimer's treatment in different genetic groups

Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers: A Randomized Controlled Trial

This study is testing if acupuncture can help people with mild-to-moderate Alzheimer's disease feel better, especially looking at how it works for those with and without a specific gene.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 176 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: Shanghai University of Traditional Chinese Medicine (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06417086 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of acupuncture in treating mild-to-moderate Alzheimer's disease, specifically comparing outcomes between APOE e4 carriers and non-carriers. Participants will receive either acupuncture or sham acupuncture three times a week for 12 weeks, alongside donepezil, with follow-up assessments over a year. The study will measure cognitive improvements using the ADAS-cog score and will also analyze plasma and neuroimaging biomarkers for a comprehensive evaluation of treatment effects.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50-85 diagnosed with mild-to-moderate Alzheimer's disease, specifically those who are either APOE e4 carriers or non-carriers.

Not a fit: Patients with cognitive impairment due to conditions other than Alzheimer's disease, such as vascular dementia or frontotemporal dementia, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, non-pharmacological treatment option for patients with Alzheimer's disease.

How similar studies have performed: While acupuncture has been explored in various contexts, this specific approach targeting Alzheimer's disease in APOE e4 carriers and non-carriers is relatively novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Shanghai

• Longhua Hospital, Shanghai University of Traditional Chinese Medicine — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Yijun Zhan

Conditions Alzheimer Disease; Cognitive Impairment