The Effect of Sequential Therapy on Alzheimer's Disease

Sponsor
Dongzhimen Hospital, Beijing
Study ID
NCT07768579
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Study Details

The goal of this observational study is to learn how Alzheimer's disease changes over time in people at different stages of the disease. It will look at changes in memory and thinking, daily activities, behavior, and traditional Chinese medicine symptom patterns. It will also learn about the outcomes and safety of sequential traditional Chinese medicine treatment based on the stage of Alzheimer's disease. The main questions this study aims to answer are: * How do memory and thinking, daily activities, behavior, and traditional Chinese medicine symptom patterns naturally change over time in participants with early-, middle-, and late-stage Alzheimer's disease? * How do symptoms and traditional Chinese medicine symptom patterns change together as Alzheimer's disease progresses? * Do participants receiving stage-based sequential traditional Chinese medicine treatment have different changes in memory and thinking, daily activities, behavior, and overall disease status? * What medical problems or side effects occur during sequential traditional Chinese medicine treatment? About 600 participants aged 55 to 85 years will take part in this study. Participants will be followed for 12 months. Participants will: * Visit the study center at the start of the study and at 3, 6, 9, and 12 months. * Complete assessments of memory and thinking, daily activities, behavior, overall disease status, and traditional Chinese medicine symptoms. * Have blood tests and other study examinations. * Have their treatment use and medical problems recorded during follow-up.

Key Dates

First listed
Aug 17, 2026
Start date
Apr 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Early-Stage AD With Kidney-Tonifying Formula
    Participants with early-stage Alzheimer's disease who receive the Kidney-Tonifying Formula and meet the prespecified exposure criteria. Kidney-Tonifying Formula：Qinggong Shoutao Pills (Daren Tang) contain donkey kidney, deer kidney, dog kidney, ginseng, Tian Dong, Mai Dong, goji berry, Rehmannia root, Dang Gui, salt-processed Yi Zhi, stir-fried Suan Zao Ren, charred Fen Xin Mu, and other ingredients. The prescribed dose is 50 pills (7 g) orally twice daily.
  • Arm: Middle-Stage AD With Kidney-Tonifying and Phlegm-Resolving Formula
    Participants with middle-stage Alzheimer's disease who receive the Kidney-Tonifying and Phlegm-Resolving Formula and meet the prespecified exposure criteria. Kidney-Tonifying and Phlegm-Resolving Formula：Modified Huanshaodan consists of prepared Rehmannia root 10 g, Chinese yam 10 g, Niu Xi 9 g, goji berry 10 g, Shan Zhu Yu 10 g, Poria 15 g, Du Zhong 10 g, processed Yuan Zhi 9 g, Wu Wei Zi 10 g, Shi Chang Pu 3 g, Ba Ji Tian 10 g, Cistanche tubulosa 10 g, ginseng 9 g, and Yu Jin (Guangxi E Zhu) 9 g. One packet is taken orally twice daily.
  • Arm: Late-Stage AD With Kidney-Tonifying and Collapse-Preventing Formula
    Participants with late-stage Alzheimer's disease who receive the Kidney-Tonifying and Collapse-Preventing Formula and meet the prespecified exposure criteria. Kidney-Tonifying and Collapse-Preventing Formula：Modified Yiwang Shuangquandan consists of ginseng 9 g, Qian Shi 15 g, Chinese yam 10 g, Mai Dong 10 g, Wu Wei Zi 10 g, Suan Zao Ren 10 g, Yuan Zhi 6 g, Shi Chang Pu 3 g, Dang Gui 10 g, Sang Piao Xiao 5 g, prepared Rehmannia root 10 g, Shan Zhu Yu 10 g, Huang Qi 5 g, Huang Lian 3 g, Mu Dan Pi 10 g, and Tu Si Zi 10 g. One packet is taken orally twice daily.
  • Arm: Non-Exposed Group
    Participants who do not receive the study medication, have medication adherence below 80%, discontinue treatment during follow-up, or do not complete the prespecified follow-up period are classified as the non-exposed group.

Primary Outcome Measure

Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) [ Time Frame: Baseline to Month 12 ]

Central Contacts

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