Sequential Traditional Chinese Medicine in Alzheimer's Disease: See How Symptoms Change Over Time

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective cohort study observes how cognitive function, daily living activities, and neuropsychiatric symptoms change as Alzheimer's disease progresses through early, middle, and late stages. It also tracks traditional Chinese medicine syndrome patterns and their relationship to clinical symptoms over time. The study aims to describe natural disease progression, assess stage-based TCM therapy outcomes, and evaluate safety in real-world use. Participants are followed with clinical scales, blood tests, MRI or PET imaging, and informed by stage-specific TCM interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Pregnancy, breastfeeding, or plans for pregnancy in the near future.
* Gastrointestinal diseases that may affect drug absorption.
* Use of medications affecting cognitive function within 4 weeks before enrollment.
* Recent participation in or current participation in another trial.

Where it's running

• Dongzhimen Hospital, Beijing University of Chinese Medicine
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: JinZhou Tian — Dongzhimen Hospital, Beijing
• Study coordinator: JinZhou Tian
• Email: jztian@hotmail.com
• Phone: +86 10 84011920

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.