Alzheimer Disease (AD)Early Phase 1NCT07208344
Intravenous Infusion of Umbilical Cord Blood as an Adjunctive Treatment for Alzheimer's Disease
A Early Phase 1 study testing Intravenous infusion of mononuclear cells from umbilical cord blood and Conventional medical treatment：donepezil, rivastigmine or galantamine in people with Alzheimer Disease (AD), run by Anhui Provincial Hospital at 1 site in China.
Trial summary
This study is a single-center, prospective, double-blind, randomized controlled clinical trial (RCT). Employing a parallel-group design, the trial plans to enroll 30 clinically diagnosed AD patients, who will be randomly assigned via a computerized randomization tool into three equal groups: low-dose, high-dose, and… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Alzheimer Disease (AD)
- What is being tested?
- Intravenous infusion of mononuclear cells from umbilical cord blood and Conventional medical treatment：donepezil, rivastigmine or galantamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2025to 30 Jun 2026
- Phase
- Early Phase 1
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 50 - 75 years old, gender not restricted;
- Patients diagnosed with Alzheimer's disease (AD) according to the AT(N) diagnostic framework (with positive amyloid protein PET test results);
- MMSE score between 15 and 30 points, patients with mild to moderate Alzheimer's disease;
- The patient has a fixed caregiver who is willing to accompany the patient throughout the corresponding program;
- The patient has a literacy level above primary school, sufficient to complete the tests stipulated in the program;
- The patient or the guardian consents to participate in this clinical trial voluntarily and signs the informed consent form.
Who cannot join
- Dementia caused by other diseases, such as vascular dementia, frontotemporal dementia, and Lewy body dementia, etc.;
- The patient has other major systemic diseases, malignant tumors, chronic obstructive pulmonary disease or pulmonary fibrosis, etc. related to the lungs;
- The patient's white blood cell and neutrophil levels are below the normal lower limit;
- The patient has active infectious diseases, such as syphilis, AIDS, hepatitis B, hepatitis C;
- The patient has a history of stroke, epilepsy, alcohol abuse, or abuse of psychotropic drugs;
- Severe visual or hearing impairment, or those who cannot complete the relevant assessment due to other reasons;
- Patients who have participated in other clinical trials within the last 2 months;
- Other situations that the researchers consider not suitable for participating in clinical research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of the University of Science and Technology of China
Hefei, Anhui, 230000
About this study
Official title: A Randomized Double-blind Clinical Study on the Use of Umbilical Cord Blood as an Adjuvant Therapy to Improve Cognitive Function in Alzheimer's Disease and Its Mechanism of Action
This study is a single-center, prospective, double-blind, randomized controlled clinical trial (RCT).
Employing a parallel-group design, the trial plans to enroll 30 clinically diagnosed AD patients, who will be randomly assigned via a computerized randomization tool into three equal groups: low-dose, high-dose, and control (10 patients per group).
Read more
The blinded clinical trial consists of three phases:
Screening Phase: All enrolled patients must provide fully informed consent and meet inclusion criteria while avoiding exclusion criteria. Baseline assessments will be recorded, and single-cell omics samples will be collected. Patients may voluntarily opt for cerebrospinal fluid (CSF) sampling.
The umbilical cord blood (UCB) used clinically is sourced from the Shandong Cord Blood Hematopoietic Stem Cell Bank. Following erythrocyte and granulocyte depletion via lymphocyte separation and density gradient centrifugation, the UCB is purified to reduce immunogenicity and undergoes genetic screening to exclude the APOE4 risk allele.
Treatment Phase: In addition to standard care, patients will receive intravenous infusions at weekly intervals for four sessions. A fifth infusion will be administered one month after the fourth. The low-dose group receives 1×10⁸ UCB-derived mononuclear cells (UCB-MNCs) per infusion, the high-dose group receives 3×10⁸ UCB-MNCs, and the control group receives an equivalent volume of saline placebo.
All clinically administered UCB-MNCs undergo genetic screening to exclude the APOE4 risk allele.
Follow-up Phase:
Assessments will be conducted at 30 days (1 month), 60 days (2 months), 90 days (3 months), and 180 days (6 months) post-initial infusion, including:
- CDR-SB scale scoring;
- Total and subdomain scores of the Activities of Daily Living (ADL) scale;
- Serum inflammatory cytokines (IL-1, IL-2, IL-6, IL-8, IL-10, TNF-α), AD biomarkers (P-tau181, P-tau217), and other relevant markers;
- Single-cell omics sample collection;
- Optional CSF sampling per patient preference.
After database lock, unblinding will occur for subsequent analysis.
- Conditions
- Alzheimer Disease (AD)
- Being tested
- Intravenous infusion of mononuclear cells from umbilical cord blood, Conventional medical treatment：donepezil, rivastigmine or galantamine
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous infusion of mononuclear cells from umbilical cord bloodBiological
When performing cell infusion, it is essential to use an infusion set and follow the standard blood transfusion procedures. Before, during, and after the infusion, monitor the patient's body temperature, pulse, breathing, and blood pressure. When infusing cells, first flush the tube with 20-30 ml of 0.9% sodium chloride, and start the infusion at a rate of 20-30 drops per minute. After half an hour, if there are no adverse reactions, increase the rate to 30-50 drops per minute. During the cell infusion process, gently shake the cell bag once every 15 minutes. After the infusion is completed, flush the cell preservation bag with 20 ml of 0.9% sodium chloride and gently shake it. After that, use 0.9% sodium chloride to rinse the infusion set to remove the cells completely, to ensure the quantity of cell infusion.
Conventional medical treatment：donepezil, rivastigmine or galantamineDrug
The treatment is carried out using drugs such as cholinesterase inhibitors (ChEI) which are suitable for mild to moderate Alzheimer's disease. For example, donepezil, rivastigmine, galantamine, etc. The frequency and dosage of drug administration should be in accordance with the instructions provided by the drug manufacturer.The patient should maintain the stability of the medication regimen throughout the entire study period.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The conventional treatment plan was supplemented with intravenous injection of normal saline (in a blinded manner) Receives: Drug: Conventional medical treatment：donepezil, rivastigmine or galantamine |
| Low-dose group | Experimental | In addition to the conventional treatment regimen, intravenous infusion of umbilical cord blood mononuclear cells (1×10^8 cells per infusion) will be administered. The infusions will be carried out via the intravenous route at one - week intervals for a total of four consecutive times. One month after the completion of the fourth infusion, the fifth infusion will be performed. Receives: Biological: Intravenous infusion of mononuclear cells from umbilical cord blood; Drug: Conventional medical treatment：donepezil, rivastigmine or galantamine |
| High-dose group | Experimental | In addition to the conventional treatment regimen, intravenous infusion of umbilical cord blood mononuclear cells (3×10^8 cells per infusion) will be administered. The infusions will be carried out via the intravenous route at one - week intervals for a total of four consecutive times. One month after the completion of the fourth infusion, the fifth infusion will be performed. Receives: Biological: Intravenous infusion of mononuclear cells from umbilical cord blood; Drug: Conventional medical treatment：donepezil, rivastigmine or galantamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
The Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) assesses cognitive functions through six different sub-items, including memory, orientation, judgment and problem-solving ability, social skills, family life and hobbies, and self-care ability.
The total score of CDR-SB ranges from 0 to 18. The higher the score, the worse the patient's cognitive function and daily living ability.
This helps to provide a more comprehensive understanding of the patient's cognitive functions in all aspects.
The assessors need to undergo professional training, be familiar with the assessment methods and scoring criteria, and avoid being influenced by subjective factors in the assessment results.
During the assessment process, it is necessary to have adequate communication with the respondents and caregivers to understand the medical history and living conditions, in order to obtain more accurate information.
Measured: Baseline, 1st, 2nd, 3rd and 6th month after treatment
Activity of Daily Living Scale（ADL）
Activity of Daily Living Scale（ADL） is commonly used to assess the daily living abilities of the elderly, and it plays a crucial role in the screening of Alzheimer's disease (AD) and mild cognitive impairment (MCI).
The minimum score is 16 (which is completely normal). Scores above 16 indicate varying degrees of functional decline, with the maximum being 56.
The ADL scale consists of 14 items and is divided into two parts: the first part is the self-care scale for physical activities, including activities such as using the toilet, eating, dressing, daily hygiene, walking, and bathing. The second part is the instrumental daily living ability scale, including activities such as making phone calls, shopping, cooking, housework, taking public transportation, taking medicine, and managing finances.
Measured: Baseline, 1st, 2nd, 3rd and 6th month after treatment
Secondary outcomes (6)
Serum levels of AD markers (P-tau181, 217)
The level of P-tau 181 shows a strong correlation with the density of Tau tangles in the brain. The levels of P-tau 181 in the cerebrospinal fluid and blood of patients with Alzheimer's disease were significantly higher than those of patients with other neurodegenerative diseases and the normal population. The increase in P-tau 217 is closely related to another core pathological feature of the brain - the deposition of β-amyloid plaques.
At the corresponding time point, blood samples (1.5 - 3 mL) were taken from the patients, and the levels of P-tau 181 and P-tau 217 were quantified using chemiluminescent enzyme immunoassay (cLEIA).
Measured: Baseline, 1st, 2nd, 3rd and 6th month after treatment
Cerebrospinal fluid(CSF) levels of AD markers (P-tau181, 217)
The level of P-tau 181 shows a strong correlation with the density of Tau tangles in the brain. The levels of P-tau 181 in the cerebrospinal fluid and blood of patients with Alzheimer's disease were significantly higher than those of patients with other neurodegenerative diseases and the normal population. The increase in P-tau 217 is closely related to another core pathological feature of the brain - the deposition of β-amyloid plaques. At the corresponding time point, a sample of the patient's cerebrospinal fluid (1-2 mL) was collected, and the levels of P-tau 181 and P-tau 217 in it were quantified using chemiluminescent enzyme immunoassay (cLEIA).
Measured: Baseline, 2nd month after treatment
Minimum Mental State Examination（MMSE）Scores
MMSE, which stands for Mini-Mental State Examination, was developed by Forstmann et al. in 1975 and is a widely used cognitive function screening tool in clinical and research settings. Its main purpose is to quickly and effectively assess the cognitive status of the subjects, especially to screen for the presence of cognitive impairments (such as dementia).
The lowest score on the scale is 0 (indicating the most severe condition), and the highest score is 30 (indicating complete normality).
Measured: Baseline, 1st, 2nd, 3rd and 6th month after treatment
Montreal Cognitive Assessment（MoCA）
The Montreal Cognitive Assessment (MoCA) scale was developed by Professor Nasreddine in 2004 as an assessment tool for rapid screening of mild cognitive impairment (MCI). The cognitive domains evaluated include attention and concentration, executive function, memory, language, visuospatial skills, abstract thinking, calculation and orientation. The total score of the scale is 30 points, with the lowest score being 0. The higher the score, the better the performance of the test subject. The test result is considered normal if it is ≥ 26 points.
Measured: Baseline, 1st, 2nd, 3rd and 6th month after treatment
Alzheimer disease assessment scale-cognitive component (ADAS-Cog)
The Alzheimer disease assessment scale - cognitive component (ADAS-cog) is one of the most widely used general cognitive measurement methods in clinical trials of Alzheimer's disease. It consists of 12 items and can assess the severity of cognitive symptoms in AD and changes in treatment. It is often used for the efficacy evaluation of mild to moderate AD (typically, a 4-point improvement is regarded as the clinical criterion for the effectiveness of the drug). The total score of this scale ranges from 0 (no errors or no damage) to 70 (severe damage).
Measured: Baseline, 1st, 2nd, 3rd and 6th month after treatment
tau-Positron Emission Tomography（tau-PET）
Tau-PET can specifically bind to abnormal tau proteins through intravenous injection, and directly visualize the distribution and density of neurofibrillary tangles (one of the core pathological features of Alzheimer's disease) in the brain in real time.Inspection process: A radioactive tracer is injected into the vein of the subject, and then the subject is left to wait for a period of time for the tracer to distribute in the brain. Finally, a PET scan is conducted to generate images.
Measured: Baseline, 3rd and 6th month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start31 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Shandong Qilu Stem Cells Engineering Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208344
- Sponsor's protocol ID
- AHSL-QLGXB-MNC-AD
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Clinical Study on the Use of Umbilical Cord Blood as an Adjuvant Therapy to Improve Cognitive Function in Alzheimer's Disease and Its Mechanism of Action
- ClinicalTrials.gov ID
- NCT07208344
- Acronym / sponsor ID
- AHSL-QLGXB-MNC-AD
- Conditions
- Alzheimer Disease (AD)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Collaborators
- Shandong Qilu Stem Cells Engineering Co., Ltd.
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 6 Oct 2025 (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.
This study is a single-center, prospective, double-blind, randomized controlled clinical trial (RCT).
Employing a parallel-group design, the trial plans to enroll 30 clinically diagnosed AD patients, who will be randomly assigned via a computerized randomization tool into three equal groups: low-dose, high-dose, and control (10 patients per group).
The blinded clinical trial consists of three phases:
Screening Phase: All enrolled patients must provide fully informed consent and meet inclusion criteria while avoiding exclusion criteria. Baseline assessments will be recorded, and single-cell omics samples will be collected. Patients may voluntarily opt for cerebrospinal fluid (CSF) sampling.
The umbilical cord blood (UCB) used clinically is sourced from the Shandong Cord Blood Hematopoietic Stem Cell Bank. Following erythrocyte and granulocyte depletion via lymphocyte separation and density gradient centrifugation, the UCB is purified to reduce immunogenicity and undergoes genetic screening to exclude the APOE4 risk allele.
Treatment Phase: In addition to standard care, patients will receive intravenous infusions at weekly intervals for four sessions. A fifth infusion will be administered one month after the fourth. The low-dose group receives 1×10⁸ UCB-derived mononuclear cells (UCB-MNCs) per infusion, the high-dose group receives 3×10⁸ UCB-MNCs, and the control group receives an equivalent volume of saline placebo.
All clinically administered UCB-MNCs undergo genetic screening to exclude the APOE4 risk allele.
Follow-up Phase:
Assessments will be conducted at 30 days (1 month), 60 days (2 months), 90 days (3 months), and 180 days (6 months) post-initial infusion, including:
- CDR-SB scale scoring;
- Total and subdomain scores of the Activities of Daily Living (ADL) scale;
- Serum inflammatory cytokines (IL-1, IL-2, IL-6, IL-8, IL-10, TNF-α), AD biomarkers (P-tau181, P-tau217), and other relevant markers;
- Single-cell omics sample collection;
- Optional CSF sampling per patient preference.
After database lock, unblinding will occur for subsequent analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Conventional medical treatment：donepezil, rivastigmine or galantamineThe conventional treatment plan was supplemented with intravenous injection of normal saline (in a blinded manner) |
| Low-dose group | Experimental | Biological: Intravenous infusion of mononuclear cells from umbilical cord blood, Drug: Conventional medical treatment：donepezil, rivastigmine or galantamineIn addition to the conventional treatment regimen, intravenous infusion of umbilical cord blood mononuclear cells (1×10^8 cells per infusion) will be administered. The infusions will be carried out via the intravenous route at one - week intervals for a total of four consecutive times. One month after the completion of the fourth infusion, the fifth infusion will be performed. |
| High-dose group | Experimental | Biological: Intravenous infusion of mononuclear cells from umbilical cord blood, Drug: Conventional medical treatment：donepezil, rivastigmine or galantamineIn addition to the conventional treatment regimen, intravenous infusion of umbilical cord blood mononuclear cells (3×10^8 cells per infusion) will be administered. The infusions will be carried out via the intravenous route at one - week intervals for a total of four consecutive times. One month after the completion of the fourth infusion, the fifth infusion will be performed. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range: 50 - 75 years old, gender not restricted;
- Patients diagnosed with Alzheimer's disease (AD) according to the AT(N) diagnostic framework (with positive amyloid protein PET test results);
- MMSE score between 15 and 30 points, patients with mild to moderate Alzheimer's disease;
- The patient has a fixed caregiver who is willing to accompany the patient throughout the corresponding program;
- The patient has a literacy level above primary school, sufficient to complete the tests stipulated in the program;
Key exclusion criteria (8 listed)
- Dementia caused by other diseases, such as vascular dementia, frontotemporal dementia, and Lewy body dementia, etc.;
- The patient has other major systemic diseases, malignant tumors, chronic obstructive pulmonary disease or pulmonary fibrosis, etc. related to the lungs;
- The patient's white blood cell and neutrophil levels are below the normal lower limit;
- The patient has active infectious diseases, such as syphilis, AIDS, hepatitis B, hepatitis C;
- The patient has a history of stroke, epilepsy, alcohol abuse, or abuse of psychotropic drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous infusion of mononuclear cells from umbilical cord bloodWhen performing cell infusion, it is essential to use an infusion set and follow the standard blood transfusion procedures. Before, during, and after the infusion, monitor the patient's body temperature, pulse, breathing, and blood pressure. When infusing cells, first flush the tube with 20-30 ml of 0.9% sodium chloride, and start the infusion at a rate of 20-30 drops per minute. After half an hour, if there are no adverse reactions, increase the rate to 30-50 drops per minute. During the cell infusion process, gently shake the cell bag once every 15 minutes. After the infusion is completed, flush the cell preservation bag with 20 ml of 0.9% sodium chloride and gently shake it. After that, use 0.9% sodium chloride to rinse the infusion set to remove the cells completely, to ensure the quantity of cell infusion. | Biological | High-dose group, Low-dose group |
| Conventional medical treatment：donepezil, rivastigmine or galantamineThe treatment is carried out using drugs such as cholinesterase inhibitors (ChEI) which are suitable for mild to moderate Alzheimer's disease. For example, donepezil, rivastigmine, galantamine, etc. The frequency and dosage of drug administration should be in accordance with the instructions provided by the drug manufacturer.The patient should maintain the stability of the medication regimen throughout the entire study period. | Drug | Control group, High-dose group, Low-dose group |
Primary outcome
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Time frame: Baseline, 1st, 2nd, 3rd and 6th month after treatment
The Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) assesses cognitive functions through six different sub-items, including memory, orientation, judgment and problem-solving ability, social skills, family life and hobbies, and self-care ability. The total score of CDR-SB ranges from 0 to 18. The higher the score, the worse the patient's cognitive function and daily living ability. This helps to provide a more comprehensive understanding of the patient's cognitive functions in all aspects. The assessors need to undergo professional training, be familiar with the assessment methods and scoring criteria, and avoid being influenced by subjective factors in the assessment results. During the assessment process, it is necessary to have adequate communication with the respondents and caregivers to understand the medical history and living conditions, in order to obtain more accurate information.
Activity of Daily Living Scale（ADL）
Time frame: Baseline, 1st, 2nd, 3rd and 6th month after treatment
Activity of Daily Living Scale（ADL） is commonly used to assess the daily living abilities of the elderly, and it plays a crucial role in the screening of Alzheimer's disease (AD) and mild cognitive impairment (MCI). The minimum score is 16 (which is completely normal). Scores above 16 indicate varying degrees of functional decline, with the maximum being 56. The ADL scale consists of 14 items and is divided into two parts: the first part is the self-care scale for physical activities, including activities such as using the toilet, eating, dressing, daily hygiene, walking, and bathing. The second part is the instrumental daily living ability scale, including activities such as making phone calls, shopping, cooking, housework, taking public transportation, taking medicine, and managing finances.
6 secondary outcomes
Serum levels of AD markers (P-tau181, 217)
Time frame: Baseline, 1st, 2nd, 3rd and 6th month after treatment
Cerebrospinal fluid(CSF) levels of AD markers (P-tau181, 217)
Time frame: Baseline, 2nd month after treatment
Minimum Mental State Examination（MMSE）Scores
Time frame: Baseline, 1st, 2nd, 3rd and 6th month after treatment
Montreal Cognitive Assessment（MoCA）
Time frame: Baseline, 1st, 2nd, 3rd and 6th month after treatment
Alzheimer disease assessment scale-cognitive component (ADAS-Cog)
Time frame: Baseline, 1st, 2nd, 3rd and 6th month after treatment
tau-Positron Emission Tomography（tau-PET）
Time frame: Baseline, 3rd and 6th month after treatment
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 6 Oct 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intravenous infusion of mononuclear cells from umbilical cord blood and Conventional medical treatment：donepezil, rivastigmine or galantamine in people with Alzheimer Disease (AD), run by Anhui Provincial Hospital 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 6 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 6 Oct 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhaozhao Cheng (+8613965140655, chengzz@USTC.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (time frame: Baseline, 1st, 2nd, 3rd and 6th month after treatment). The study lists 2 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 6 Oct 2025.