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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Alzheimer's Disease Assessment Scale-cognition (ADAS-cog) [Срок оценки: Change from baseline to Week 12]

Вторичные конечные точки (3)

• Alzheimer's Disease Assessment Scale-cognition (ADAS-cog) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Longhua Hospital, Shanghai University of Traditional Chinese Medicine — Шанхай

Идентификаторы

NCT: NCT06417086 · 23Y11921000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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