The Effect of Sequential Therapy on Alzheimer's Disease
Recruiting · NCT07768579 · Observational (researchers observe without assigning treatment) · Lead sponsor: Dongzhimen Hospital, Beijing
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Dongzhimen Hospital, Beijing University of Chinese Medicine - Beijing, Beijing Municipality, China