The Effect of Sequential Therapy on Alzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-85
SponsorDongzhimen Hospital, Beijing
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population consists of participants with different stages of Alzheimer's disease recruited from Dongzhimen Hospital, Beijing University of Chinese Medicine, and participating study centers. Recruitment settings include brain disease departments, neurology departments, memory clinics, and traditional Chinese medicine outpatient clinics. Participants include individuals with mild cognitive impairment due to Alzheimer's disease and those with mild, moderate, or severe Alzheimer's dementia.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 4 trial groupsGroup A: Early-Stage AD With Kidney-Tonifying Formula
Group B: Middle-Stage AD With Kidney-Tonifying and Phlegm-Resolving Formula
Group C: Late-Stage AD With Kidney-Tonifying and Collapse-Preventing Formula
Group D: Non-Exposed Group
Trial outcomes
Primary outcomes
1
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
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.
Time frame
Baseline to Month 122
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog11)
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.
Time frame
Baseline to Month 123
Change From Baseline in Severe Impairment Battery (SIB)
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.
Time frame
Baseline to Month 12Secondary outcomes
1
Change From Baseline in Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) is used to assess cognitive function. The total score ranges from 0 to 30, with higher scores indicating better cognitive function and a better outcome. The outcome is the change in MMSE score from baseline to Month 12.
Time frame
Baseline to Month 122
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
The Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) is used to assess performance of activities of daily living. The total score ranges from 0 to 78, with higher scores indicating greater independence in daily functioning and a better outcome. The outcome is the change in ADCS-ADL score from baseline to Month 12.
Time frame
Baseline to Month 123
Change From Baseline in Neuropsychiatric Inventory (NPI)
The Neuropsychiatric Inventory (NPI) is used to assess neuropsychiatric symptoms. The 12-domain total score ranges from 0 to 144, with higher scores indicating more severe neuropsychiatric symptoms and a worse outcome. The outcome is the change in NPI score from baseline to Month 12.
Time frame
Baseline to Month 124
Change From Baseline in Blood Aβ42/Aβ40 Ratio
The blood amyloid beta 42 to amyloid beta 40 (Aβ42/Aβ40) ratio will be measured at baseline and Month 12. The Aβ42/Aβ40 ratio is a dimensionless value. The outcome is the change in the Aβ42/Aβ40 ratio from baseline to Month 12.
Time frame
Baseline to Month 12Other outcomes
1
Incidence of Adverse Events
The number and proportion of participants experiencing adverse events during traditional Chinese medicine use and follow-up. Adverse events include any unfavorable medical events occurring during treatment or follow-up, including symptoms, signs, or laboratory abnormalities, regardless of whether they are considered related to treatment.
Time frame
Up to 12 months2
Incidence of Serious Adverse Events
The number and proportion of participants experiencing serious adverse events during the study follow-up period.
Time frame
Up to 12 months3
Change From Baseline in Kidney Deficiency Score Assessed by the Revised Pattern Elements Scale in Alzheimer's Disease （PES-AD）
Kidney deficiency is assessed using the kidney deficiency subscale of the Revised Pattern Elements Scale in Alzheimer's Disease (PES-AD). The score ranges from 0 to 21, with higher scores indicating a greater degree of kidney deficiency and therefore a worse pattern outcome. A score of 7 or higher indicates the presence of the kidney deficiency pattern element. The outcome is the change from baseline in the kidney deficiency score at each follow-up assessment.
Time frame
Baseline and Months 3, 6, 9, and 124
Change From Baseline in Phlegm Obstruction Score Assessed by the Revised Pattern Elements Scale in Alzheimer's Disease (PES-AD)
Phlegm obstruction is assessed using the phlegm obstruction subscale of the Revised Pattern Elements Scale in Alzheimer's Disease (PES-AD). The score ranges from 0 to 20, with higher scores indicating a greater degree of phlegm obstruction and therefore a worse pattern outcome. A score of 7 or higher indicates the presence of the phlegm obstruction pattern element. The outcome is the change from baseline in the phlegm obstruction score at each follow-up assessment.
Time frame
Baseline and Months 3, 6, 9, and 12Sponsors and contacts
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Source ClinicalTrials.gov