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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06417086
• Other study ID #: 23Y11921000
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: May 2024
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Yijun Zhan
• Phone: +8618917699167
• Email: jenniferzhan_lhzj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Impairment

Intervention

Other:
• Acupuncture
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
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.

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

Locations

Country	Name	City	State
China	Longhua Hospital, Shanghai University of Traditional Chinese Medicine	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Shanghai Minimally Invasive Surgery Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Phosphorylated tau at threonine 181 (p-tau181)	Plasma p-tau181measured by Single Molecule Array (Simoa) as the plasma biomarker.	Change from baseline to Week 12 and Week 64 (Follow-up 2)
Other	Cerebral Blood Flow (CBF)	CBF acquired by arterial spin labeling (ASL) magnetic resonance imaging (MRI) technique measures the blood flow condition of the whole brain.	Change from baseline to Week 12 and Week 64 (Follow-up 2)
Primary	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	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 38 (Follow-up 1) and Week 64 (Follow-up 2)
Secondary	Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL)	The maximum of the ADCS-ADL score is 54 containing 19 domains about assessment of basic and operational ability of daily living. The higher scores indicate higher ability of daily living.	Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2)
Secondary	Quality of Life-Alzheimer's Disease(QOL-AD)	The QOL-AD score includes 13 items about physical health, mental health, social and financial assessment, and quality of life. The total score ranges from 13 to 52. The higher scores indicate higher quality of life.	Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2)