An observational study in Mild Cognitive Impairment Due to Alzheimer Disease and Alzheimer Disease, sponsored by Dongzhimen Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Dongzhimen Hospital, Beijing · Observational
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:
About 600 participants aged 55 to 85 years will take part in this study. Participants will be followed for 12 months.
Participants will:
Alzheimer's disease has a progressive clinical course, and traditional Chinese medicine theory describes changes in syndrome patterns across different stages of the disease. In the early stage, kidney deficiency is considered the predominant pattern. In the middle stage, phlegm, fire, and blood stasis may become more prominent, while the late stage is characterized by severe qi deficiency. Based on this stage-related evolution, a sequential traditional Chinese medicine approach was developed according to the "syndrome cascade hypothesis." Preliminary clinical observations have suggested potential benefits for cognitive function and overall clinical status, but evidence from prospective multicenter studies remains limited.
This prospective multicenter cohort study has three main objectives. First, it will describe the natural changes in cognitive function, activities of daily living, neuropsychiatric symptoms, and traditional Chinese medicine syndrome patterns across the early, middle, and late stages of Alzheimer's disease. It will also characterize the dynamic relationship between clinical symptoms and traditional Chinese medicine syndrome patterns during disease progression. Second, it will evaluate the clinical outcomes associated with stage-based sequential traditional Chinese medicine therapy, including short- and long-term clinical changes. Third, it will evaluate the safety of sequential traditional Chinese medicine therapy in real-world clinical use.
Treatment exposure will be recorded prospectively. Exposure assessment will consider cumulative medication use, medication adherence, treatment continuity, and treatment interruption. Information from medication dispensing and return records, medication diaries, and investigator follow-up records will be used to assess treatment exposure. The time from the beginning of treatment exposure to subsequent outcome assessment will also be recorded.
General demographic and baseline clinical characteristics will be summarized using descriptive statistics. Continuous outcomes will be analyzed using linear mixed-effects models to evaluate changes over time. The models will include time, exposure status, and the interaction between time and exposure status. Single-time-point comparisons may use independent-samples tests or analysis of covariance, as appropriate. Binary outcomes will be analyzed using logistic regression, with adjustment for potential confounding factors when appropriate.
Prespecified subgroup analyses will explore whether the associations with sequential therapy differ according to disease stage, age, sex, baseline cognitive function, concomitant use of Western medicines, and traditional Chinese medicine syndrome type. Interaction terms between subgroup factors and exposure status will be used to explore differences among subgroups. These subgroup analyses will be considered exploratory.
Missing data patterns will be assessed to determine whether data are missing completely at random, missing at random, or missing not at random. Multiple imputation will be used for missing primary outcomes and key covariates, with variables related to missingness included in the imputation model. Sensitivity analyses will be performed to examine the robustness of the findings under different assumptions and exposure definitions.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 600 is above the median of 200 across 814 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Dongzhimen Hospital, Beijing is the lead sponsor of 45 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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 12
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 12
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 12
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 12
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 12
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 12
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 12
Change From Baseline in Blood Phosphorylated Tau 181 (P-Tau181)
Blood phosphorylated tau 181 (P-Tau181) will be measured in picograms per milliliter (pg/mL) at baseline and Month 12. The outcome is the change in P-Tau181 concentration from baseline to Month 12.
Time frame: Baseline to Month 12
Change From Baseline in Blood Phosphorylated Tau 217 (P-Tau217)
Blood phosphorylated tau 217 (P-Tau217) will be measured in picograms per milliliter (pg/mL) at baseline and Month 12. The outcome is the change in P-Tau217 concentration from baseline to Month 12.
Time frame: Baseline to Month 12
Change From Baseline in Blood Neurofilament Light Chain (NfL)
Blood neurofilament light chain (NfL) will be measured in picograms per milliliter (pg/mL) at baseline and Month 12. The outcome is the change in NfL concentration from baseline to Month 12.
Time frame: Baseline to Month 12
Change From Baseline in Blood Glial Fibrillary Acidic Protein (GFAP)
Blood glial fibrillary acidic protein (GFAP) will be measured in picograms per milliliter (pg/mL) at baseline and Month 12. The outcome is the change in GFAP concentration from baseline to Month 12.
Time frame: Baseline to Month 12
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 months
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 months
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 12
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 12
Change From Baseline in Fire Disturbance Score Assessed by the Revised Pattern Elements Scale in Alzheimer's Disease (PES-AD)
Fire disturbance is assessed using the fire disturbance 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 fire disturbance and therefore a worse pattern outcome. A score of 7 or higher indicates the presence of the fire disturbance pattern element. The outcome is the change from baseline in the fire disturbance score at each follow-up assessment.
Time frame: Baseline and Months 3, 6, 9, and 12
Change From Baseline in Blood Stasis Score Assessed by the Revised Pattern Elements Scale in Alzheimer's Disease (PES-AD)
Blood stasis is assessed using the blood stasis 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 blood stasis and therefore a worse pattern outcome. A score of 7 or higher indicates the presence of the blood stasis pattern element. The outcome is the change from baseline in the blood stasis score at each follow-up assessment.
Time frame: Baseline and Months 3, 6, 9, and 12
Change From Baseline in Yang Deficiency Score Assessed by the Revised Pattern Elements Scale in Alzheimer's Disease (PES-AD)
Yang deficiency is assessed using the Yang 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 Yang deficiency and therefore a worse pattern outcome. A score of 7 or higher indicates the presence of the Yang deficiency pattern element. The outcome is the change from baseline in the Yang deficiency score at each follow-up assessment.
Time frame: Baseline and Months 3, 6, 9, and 12
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Dongzhimen Hospital, Beijing