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Clinical Trials in China / NCT07768579
Recruiting Observational

The Effect of Sequential Therapy on Alzheimer's Disease

NCT07768579 · tracked via the Priya Life Science China tracker
Sponsor
Dongzhimen Hospital, Beijing
Phase
Observational
Started
2026-04-30
Last updated
2026-08-19

Condition(s) studied

Mild Cognitive Impairment Due to Alzheimer DiseaseAlzheimer Disease

Study summary

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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) — Baseline to Month 12
    The Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) is used to assess overall cognitive and functional impairment. The total score ranges from 0 to 18, with higher scores indicating greater disease severity and a worse outcome. The outcome is the change in CDR-SB score from baseline to Month 12.
  • Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog11) — Baseline to Month 12
    The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is used to assess cognitive impairment in participants with early- and middle-stage Alzheimer's disease. The standard 11-item ADAS-Cog total score ranges from 0 to 70, with higher scores indicating greater cognitive impairment and a worse outcome. The outcome is the change in ADAS-Cog score from baseline to Month 12.
  • Change From Baseline in Severe Impairment Battery (SIB) — Baseline to Month 12
    The Severe Impairment Battery (SIB) is used to assess cognitive function in participants with late-stage Alzheimer's disease. The total score ranges from 0 to 100, with higher scores indicating better cognitive function and a better outcome. The outcome is the change in SIB score from baseline to Month 12.

Trial sites (1)

FacilityCityRegionStatus
Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing Beijing Municipality Recruiting

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Other trials for the same condition

Implantable Vagus Nerve Stimulation Modulation of Coeruleus-Norepinephrine Network for Mild-Moderate AD Patients Starting soon
A Master Protocol Studying Multiple Amyloid-Targeting Therapies in Healthy Participants and Participants With Alzheimer's Disease Recruiting
China Longitudinal Aging and Cognitive Impairment Study Recruiting
Clinical Applicantion of Multi-Tracer PET/MR Imaging in Neurological Disorders/Disease Recruiting
Transcranial Near-infrared Light Therapy for Mild-Moderate Alzheimer's Disease (NIR4AD) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07768579 on ClinicalTrials.gov ↗ ← All trials in China