Mild Cognitive Impairment Due to Alzheimer DiseaseNCT07768579
The Effect of Sequential Therapy on Alzheimer's Disease
An observational study of Mild Cognitive Impairment Due to Alzheimer Disease and Alzheimer Disease, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment Due to Alzheimer Disease, Alzheimer Disease
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jing Shi contact
China1 site, 1 recruiting
- Recruiting
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100700
Jinzhou Tian, +86 10 84011920, jztian@hotmail.com
Jing Shi, shijing87@hotmail.com
About this study
Official title: The Effect of Sequential Therapy on Alzheimer's Disease: A Prospective Cohort Study
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?
Read more
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.
Read the detailed description
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.
- Keywords
- Sequential Therapy, Traditional Chinese Medicine, Alzheimer Disease, Mild Cognitive Impairment Due to Alzheimer Disease, Cognitive Function, Traditional Chinese Medicine Syndrome
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early-Stage AD With Kidney-Tonifying Formula | 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. | |
| Middle-Stage AD With Kidney-Tonifying and Phlegm-Resolving Formula | 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. | |
| Late-Stage AD With Kidney-Tonifying and Collapse-Preventing Formula | 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. | |
| Non-Exposed Group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to Month 12
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start30 Apr 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment Due to Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinzhou Tian, Dongzhimen Hospital, Beijing
- Investigators
- JinZhou Tian, Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768579
- Sponsor's protocol ID
- DXMG-JBZX-25001
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sequential Therapy on Alzheimer's Disease: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07768579
- Acronym / sponsor ID
- DXMG-JBZX-25001
- Keywords
- Sequential Therapy, Traditional Chinese Medicine, Alzheimer Disease, Mild Cognitive Impairment Due to Alzheimer Disease, Cognitive Function, Traditional Chinese Medicine Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early-Stage AD With Kidney-Tonifying Formula | – | –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. |
| Middle-Stage AD With Kidney-Tonifying and Phlegm-Resolving Formula | – | –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. |
| Late-Stage AD With Kidney-Tonifying and Collapse-Preventing Formula | – | –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. |
| Non-Exposed Group | – | –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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Time frame: 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)
Time frame: 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)
Time frame: 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.
8 secondary outcomes
Change From Baseline in Mini-Mental State Examination (MMSE)
Time frame: Baseline to Month 12
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Time frame: Baseline to Month 12
Change From Baseline in Neuropsychiatric Inventory (NPI)
Time frame: Baseline to Month 12
Change From Baseline in Blood Aβ42/Aβ40 Ratio
Time frame: Baseline to Month 12
Change From Baseline in Blood Phosphorylated Tau 181 (P-Tau181)
Time frame: Baseline to Month 12
Change From Baseline in Blood Phosphorylated Tau 217 (P-Tau217)
Time frame: Baseline to Month 12
Change From Baseline in Blood Neurofilament Light Chain (NfL)
Time frame: Baseline to Month 12
Change From Baseline in Blood Glial Fibrillary Acidic Protein (GFAP)
Time frame: Baseline to Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Shi contact
JinZhou Tian principal investigator
Dongzhimen Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment Due to Alzheimer Disease and Alzheimer Disease, run by Dongzhimen Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JinZhou Tian (+86 10 84011920, jztian@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) (time frame: Baseline to Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.