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

NCT06417086 | Recruiting DMC

• 1 other identifier: 23Y11921000
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale-cognition (ADAS-cog)

  The maximum score of the ADAS-cog is 70 including 12 items. The questions in this scale contain word recall task, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition task, remembering test directions, spoken language, word-finding difficulty, comprehension and attention. In general, a normal score for someone who does not have AD or another type of dementia is 5. The higher scores indicate higher degree of cognitive dysfunction.

  Change from baseline to Week 12

Secondary Outcomes (3)

• Alzheimer's Disease Assessment Scale-cognition (ADAS-cog)

  Change from baseline to Week 38 (Follow-up 1) and Week 64 (Follow-up 2)

• Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL)

  Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2)

• Quality of Life-Alzheimer's Disease(QOL-AD)

  Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2)

Other Outcomes (2)

• Phosphorylated tau at threonine 181 (p-tau181)

  Change from baseline to Week 12 and Week 64 (Follow-up 2)

• Cerebral Blood Flow (CBF)

  Change from baseline to Week 12 and Week 64 (Follow-up 2)

Study Arms (2)

Acupuncture Treatment

EXPERIMENTAL

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

Other: Acupuncture; Drug: Donepezil

Sham Acupuncture Treatment

ACTIVE COMPARATOR

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

Other: Sham Acupuncture; Drug: Donepezil

Interventions

Acupuncture OTHER

The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. There will be 12 weeks of 3-session treatment for each participant in total.

Acupuncture Treatment

Sham Acupuncture OTHER

The Streitberger placebo needle will be used to simulate an acupuncture procedure without penetrating the skin. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. There will be 12 weeks of 3-session treatment for each participant in total.

Sham Acupuncture Treatment

Donepezil DRUG

Donepezil 5 mg will be given once daily before bed-time for 12 weeks.

Acupuncture Treatment; Sham Acupuncture Treatment

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ZhanYJ: lead
• Shanghai Minimally Invasive Surgery Center: collaborator

Study Sites (1)

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Acupuncture Therapy; Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Yijun Zhan

  Shanghai University of Traditional Chinese Medicine

  STUDY CHAIR

• Houguang Zhou

  Huashan Hospital

  STUDY DIRECTOR

Central Study Contacts

Yijun Zhan

CONTACT

+8618917699167; jenniferzhan_lhzj@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Streitberger placebo needle will be used as sham acupuncture method to mask the paticipants. The outcome assessors will also be blind to the grouping.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai University of Traditional Chinese Medicine

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 16, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

CN (1)