Following Alzheimer's disease over time, including stage-based traditional Chinese medicine treatment
Follows people with Alzheimer's disease and tracks stage-based traditional Chinese medicine treatment.
Key facts
- Who runs it
- Dongzhimen Hospital, Beijing
- Where
- Beijing, ChinaSee the site
- Trial code
- Registry title
- The Effect of Sequential Therapy on Alzheimer's Disease
- Status
- Recruiting
- People taking part
- 600 people, planned
- Started
- 30 Apr 2026
- Expected to end
- 31 Dec 2028
- Type of study
- Observational, 4 groups
- Record updated
- 19 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 55 to 85 with mild cognitive impairment due to Alzheimer's disease or mild, moderate or severe Alzheimer's dementia. It follows them for 12 months.
- Age
- 55 to 85 years
- Sex
- Men and women can both join.
- Disease stage
- Mild cognitive impairment due to Alzheimer's disease, or mild, moderate or severe Alzheimer's dementia. Memory decline for at least 6 months.
- Earlier treatment
- No medicines that affect thinking or memory in the 4 weeks before joining.
- Biomarker or test result
- Must be able to have a brain MRI or an amyloid-beta PET scan (Aβ-PET).
Main reasons for not taking part
- Other diseases that can cause thinking problems, such as stroke, head injury, thyroid problems or vitamin deficiency
- Severe heart, brain, liver or kidney problems
- HIV or HBV infection
- Pregnancy, breastfeeding or planning pregnancy soon
- Taking part in another trial recently or now
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Age 55 to 85 years, regardless of sex
- Memory decline reported by the participant or family member for at least 6 months
- Meets the diagnostic criteria for the target disease and is clinically diagnosed with mild cognitive impairment due to Alzheimer's disease or mild, moderate, or severe Alzheimer's dementia
- Able to complete clinical scale assessments and blood sampling
- Able to undergo brain magnetic resonance imaging (MRI) or amyloid-beta positron emission tomography (Aβ-PET) examinations using the tracers specified in the study protocol
- Written informed consent provided by the participant or a legally authorized representative
- Able to complete study follow-up
- Participants with a known allergy to components of the exposure medications will be assigned to the non-exposed group
Who cannot take part
- Use of medications affecting cognitive function within 4 weeks before enrollment
- Cerebrovascular disease, traumatic brain injury, thyroid dysfunction, vitamin deficiency, or other diseases sufficient to cause cognitive impairment
- Malignant tumors unrelated to the target disease, hematological diseases, severe psychiatric disorders, depression, or anxiety disorders
- Severe dysfunction of major organs, including the heart, brain, liver, or kidneys
- Infectious diseases, including HIV or HBV infection
- Gastrointestinal diseases that may affect drug absorption
- Pregnancy, breastfeeding, or plans for pregnancy in the near future
- Recent participation in or current participation in another trial
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 85 years old?
Where in China
- Dongzhimen Hospital, Beijing University of Chinese MedicineBeijing, ChinaContact: Jinzhou TianTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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.
The 4 groups in the trial
- 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.
- 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.
- 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.
- 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effect of Sequential Therapy on Alzheimer's Disease: A Prospective Cohort Study
- Plain-language title
- Following Alzheimer's disease over time, including stage-based traditional Chinese medicine treatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07768579, who can take part
- Record updated
- 19 August 2026