Frontotemporal DementiaPhase 1/2NCT07638813
MSC-Exosome Therapy for Frontotemporal Dementia
A Phase 1/2 study testing Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （Low-Dose） and Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （High-Dose） in people with Frontotemporal Dementia, run by Ruijin Hospital.
Trial summary
This study is testing a new treatment for Frontotemporal Dementia (FTD) - a progressive brain disease that affects personality, behavior, and language. Currently, there is no cure for FTD and no approved medication that can slow down or stop the disease. Existing treatments only help manage some symptoms temporarily. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Frontotemporal Dementia
- What is being tested?
- Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （Low-Dose） and Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （High-Dose）
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Oct 2027
- Phase
- Phase 1/2
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of probable frontotemporal dementia (FTD), including behavioral variant (bvFTD), semantic variant primary progressive aphasia (svPPA), or non-fluent variant primary progressive aphasia (nfvPPA), according to established diagnostic criteria, with supportive neuroimaging evidence showing frontal and/or temporal lobe atrophy score of 2 or higher on brain CT or MRI.
- Age between 30 and 80 years (inclusive) at screening.
- Study partner who agrees to participate in the study, provides at least 3 hours of daily care or visits, and can manage all study medication.
- Frontotemporal Lobar Degeneration Clinical Dementia Rating (FTLD-CDR) score of 0-2 and Mini-Mental State Examination (MMSE) score greater than 10 at screening.
- Stable use of cognition- or behavior-related medications (e.g., cholinesterase inhibitors, memantine, antidepressants, antipsychotics, mood stabilizers, benzodiazepines) for at least 30 days before baseline.
- Signed informed consent form.
Who cannot join
- History of stroke or other neurological or psychiatric disorder (other than FTD) that is considered the primary cause of behavioral symptoms.
- Pregnancy or breastfeeding, or plan to become pregnant during the study period.
- Use of any investigational or experimental drug or device within 60 days or 5 half-lives (whichever is longer) prior to screening.
- Presence of speech or language impairment that severely affects the implementation of neuropsychological assessments or safety evaluations per the study protocol.
- History of cancer, unless: (a) considered cured; (b) not actively receiving anti-cancer therapy or radiation and the investigator judges that treatment is unlikely to be needed in the next 5 years; or (c) for prostate cancer or basal cell carcinoma, no significant progression in the past 2 years.
- Any clinically significant hematologic, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disease that would interfere with study participation. Participants may be included if the condition has been stable for at least one year and the investigator judges that it does not affect participation.
- Known hypersensitivity to the study drug or any of its excipients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Via Intranasal Administration in Patients With Frontotemporal Dementia
This study is testing a new treatment for Frontotemporal Dementia (FTD) - a progressive brain disease that affects personality, behavior, and language. Currently, there is no cure for FTD and no approved medication that can slow down or stop the disease. Existing treatments only help manage some symptoms temporarily.
The investigational treatment in this study is made from exosomes - tiny particles naturally released by umbilical cord stem cells. Exosomes act like "message carriers" between cells. Researchers believe they may help protect brain cells, reduce harmful protein buildup, and improve brain function.
The exosomes will be given as a nasal spray (sprayed into the nose). This method may allow the treatment to reach the brain directly without needing to pass through the blood-brain barrier (a natural protective layer that often blocks medications from entering the brain).
- Conditions
- Frontotemporal Dementia
- Being tested
- Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （Low-Dose）, Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （High-Dose）, Placebo Comparator (0.9% NaCl)
- Keywords
- Frontotemporal Dementia, exosomes
- Medical subject headings
- Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （Low-Dose）Biological
Participants randomized to the low-dose group will receive intranasal spray of human umbilical cord mesenchymal stem cell-derived exosomes (MSC-Exos), 1 mL per administration containing 24 × 10⁹ particles, twice weekly for 24 consecutive weeks.
Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （High-Dose）Biological
Participants randomized to the high-dose group will receive intranasal spray of human umbilical cord mesenchymal stem cell-derived exosomes (MSC-Exos), 1 mL per administration containing 36 × 10⁹ particles, twice weekly for 24 consecutive weeks. Enrollment in this arm will only begin after the first 3 participants in the low-dose arm complete the 4-week safety lead-in period without dose-limiting toxicity or serious adverse events.
Placebo Comparator (0.9% NaCl)Other
Participants randomized to the placebo group will receive intranasal spray of normal saline (0.9% sodium chloride), 1 mL per administration, twice weekly for 24 consecutive weeks. The placebo is identical in appearance, packaging, and administration procedure to the active investigational product to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Participants randomized to the placebo group will receive intranasal spray of normal saline (0.9% sodium chloride), 1 mL per administration, twice weekly for 24 consecutive weeks. The placebo is identical in appearance, packaging, and administration procedure to the active investigational product to maintain blinding. Receives: Other: Placebo Comparator (0.9% NaCl) |
| Low-Dose Exosome Group | Experimental | Participants randomized to the low-dose group will receive intranasal spray of human umbilical cord mesenchymal stem cell-derived exosomes (MSC-Exos), 1 mL per administration containing 24 × 10⁹ particles, twice weekly for 24 consecutive weeks. Receives: Biological: Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （Low-Dose） |
| High-Dose MSC-Exosome | Experimental | Participants randomized to the high-dose group will receive intranasal spray of human umbilical cord mesenchymal stem cell-derived exosomes (MSC-Exos), 1 mL per administration containing 36 × 10⁹ particles, twice weekly for 24 consecutive weeks. Enrollment in this arm will only begin after the first 3 participants in the low-dose arm complete the 4-week safety lead-in without dose-limiting toxicity or serious adverse events. Receives: Biological: Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （High-Dose） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Efficacy: Change in CDR plus NACC FTLD Score
Change from baseline in the Clinical Dementia Rating (CDR®) Dementia Staging Instrument plus the National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration (NACC FTLD) module total score at Week 24.
Scale Range: Minimum = 0, Maximum = 30
Interpretation: A higher score indicates worse cognitive and behavioral function; a decrease (negative change) from baseline indicates improvement.
Measured: Baseline and Week 24
Safety and Tolerability: Incidence of Adverse Events
Number of participants with treatment-emergent adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious adverse drug reactions (SADR), including assessment of causality and severity. Adverse events include local nasal reactions (e.g., epistaxis, nasal congestion, rhinorrhea, cough, pharyngeal discomfort, sneezing, nasal dryness) and systemic reactions (e.g., rash, pruritus, facial/eyelid swelling, dyspnea, chest tightness, fever, chills). Severity graded as mild, moderate, or severe.
Measured: Baseline through Week 24 (end of treatment)
Secondary outcomes (8)
Change in Global Cognition: MMSE Score
Change from baseline in Mini-Mental State Examination (MMSE) total score. Range: 0-30, with higher scores indicating better cognitive function.
Measured: Baseline, Week 12, Week 24
Change in Global Cognition: MoCA Score
Change from baseline in Montreal Cognitive Assessment (MoCA) Basic Version total score. Range: 0-30, with higher scores indicating better cognitive function.
Measured: Baseline, Week 12, Week 24
Change in Language Function: BNT Score
Change from baseline in Boston Naming Test (BNT) total score, measuring confrontation naming ability.
Unabbreviated Scale Title: Boston Naming Test (BNT)
Scale Range: Minimum = 0, Maximum = 60
Interpretation: Higher scores indicate better language function; an increase (positive change) from baseline indicates improvement.
Measured: Baseline, Week 12, Week 24
Change in Language Function: Semantic Fluency Test
Change from baseline in the number of animals named per minute on the Semantic Fluency Test, measuring verbal fluency and lexical access.
Unabbreviated Scale Title: Semantic Fluency Test (Animal Naming)
Scale Range: Minimum = 0, Maximum = no fixed upper limit (typical range in healthy adults: 12-25; in FTD patients: 0-15)
*Note: The test is scored as the number of unique, correct animal names produced within 60 seconds. While theoretically open-ended, practical scores rarely exceed 30-40.*
Interpretation: Higher scores indicate better verbal fluency and language function; an increase (positive change) from baseline indicates improvement.
Measured: Baseline, Week 12, Week 24
Change in Neuropsychiatric Symptoms: NPI Score
Change from baseline in Neuropsychiatric Inventory (NPI) total score, assessing behavioral and psychiatric symptoms in dementia.
Unabbreviated Scale Title: Neuropsychiatric Inventory (NPI)
Scale Range: Minimum = 0, Maximum = 144
Note: The NPI assesses 12 domains (e.g., delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, motor disturbances, sleep disturbances, appetite changes, and aberrant motor behavior). Each domain is scored as frequency (1-4) × severity (1-3), for a maximum of 12 per domain.
Interpretation: Lower scores indicate fewer or less severe neuropsychiatric symptoms; a decrease (negative change) from baseline indicates improvement.
Measured: Baseline, Week 12, Week 24
Change in Neuropsychiatric Symptoms: FBI Score
Change from baseline in Frontal Behavior Inventory (FBI) total score, measuring behavioral symptoms associated with frontotemporal dysfunction.
Unabbreviated Scale Title: Frontal Behavior Inventory (FBI)
Scale Range: Minimum = 0, Maximum = 72
*Note: The FBI assesses 24 items (each scored 0-3), covering negative symptoms (e.g., apathy, indifference, loss of insight) and positive/disinhibited symptoms (e.g., impulsivity, perseveration, irritability, poor judgment).*
Interpretation: Lower scores indicate fewer or less severe frontal behavioral symptoms; a decrease (negative change) from baseline indicates improvement.
Measured: Baseline, Week 12, Week 24
Change in Executive Function: FAB Score
Change from baseline in Frontal Assessment Battery (FAB) total score, assessing executive functions including conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy.
Unabbreviated Scale Title: Frontal Assessment Battery (FAB)
Scale Range: Minimum = 0, Maximum = 18
Note: The FAB consists of 6 subtests, each scored from 0 to 3.
Interpretation: Higher scores indicate better executive function; an increase (positive change) from baseline indicates improvement.
Measured: Baseline, Week 12, Week 24
Change in Daily Function and Behavior: ADL Score
Change from baseline in Activities of Daily Living (ADL) scale total score, measuring the participant's ability to perform daily living activities.
Unabbreviated Scale Title: Barthel Index of Activities of Daily Living (or specify the actual scale used, e.g., Katz Index of Independence in Activities of Daily Living, Lawton Instrumental Activities of Daily Living Scale)
Scale Range (Barthel Index): Minimum = 0, Maximum = 100
Note: The Barthel Index assesses 10 items (e.g., feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers, mobility, stair climbing). Alternative ADL scales may have different ranges (e.g., Katz Index: 0-6).
Interpretation: Lower scores indicate worse functional status (greater dependence); higher scores indicate better functional status (greater independence). Please confirm - the provided description states "Lower scores indicate better functional status," which is atypical for most ADL scales. Usually, higher scores = better fun
Measured: Baseline, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal DementiaStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ECHO Biotech
- Responsible party
- Principal investigator, Shengdi Chen, Ruijin Hospital
- Investigators
- Shengdi Chen, MD, Ph.D, Principal investigator, Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638813
- Sponsor's protocol ID
- 2026-221
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Via Intranasal Administration in Patients With Frontotemporal Dementia
- ClinicalTrials.gov ID
- NCT07638813
- Acronym / sponsor ID
- 2026-221
- Conditions
- Frontotemporal Dementia
- Keywords
- Frontotemporal Dementia, exosomes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- ECHO Biotech
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 10 Jun 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.
This study is testing a new treatment for Frontotemporal Dementia (FTD) - a progressive brain disease that affects personality, behavior, and language. Currently, there is no cure for FTD and no approved medication that can slow down or stop the disease. Existing treatments only help manage some symptoms temporarily.
The investigational treatment in this study is made from exosomes - tiny particles naturally released by umbilical cord stem cells. Exosomes act like "message carriers" between cells. Researchers believe they may help protect brain cells, reduce harmful protein buildup, and improve brain function.
The exosomes will be given as a nasal spray (sprayed into the nose). This method may allow the treatment to reach the brain directly without needing to pass through the blood-brain barrier (a natural protective layer that often blocks medications from entering the brain).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Other: Placebo Comparator (0.9% NaCl)Participants randomized to the placebo group will receive intranasal spray of normal saline (0.9% sodium chloride), 1 mL per administration, twice weekly for 24 consecutive weeks. The placebo is identical in appearance, packaging, and administration procedure to the active investigational product to maintain blinding. |
| Low-Dose Exosome Group | Experimental | Biological: Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （Low-Dose）Participants randomized to the low-dose group will receive intranasal spray of human umbilical cord mesenchymal stem cell-derived exosomes (MSC-Exos), 1 mL per administration containing 24 × 10⁹ particles, twice weekly for 24 consecutive weeks. |
| High-Dose MSC-Exosome | Experimental | Biological: Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （High-Dose）Participants randomized to the high-dose group will receive intranasal spray of human umbilical cord mesenchymal stem cell-derived exosomes (MSC-Exos), 1 mL per administration containing 36 × 10⁹ particles, twice weekly for 24 consecutive weeks. Enrollment in this arm will only begin after the first 3 participants in the low-dose arm complete the 4-week safety lead-in without dose-limiting toxicity or serious adverse events. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of probable frontotemporal dementia (FTD), including behavioral variant (bvFTD), semantic variant primary progressive aphasia (svPPA), or non-fluent variant primary progressive aphasia (nfvPPA), according to established diagnostic criteria, with supportive neuroimaging evidence showing frontal and/or temporal lobe atrophy score of 2 or higher on brain CT or MRI.
- Age between 30 and 80 years (inclusive) at screening.
- Study partner who agrees to participate in the study, provides at least 3 hours of daily care or visits, and can manage all study medication.
- Frontotemporal Lobar Degeneration Clinical Dementia Rating (FTLD-CDR) score of 0-2 and Mini-Mental State Examination (MMSE) score greater than 10 at screening.
- Stable use of cognition- or behavior-related medications (e.g., cholinesterase inhibitors, memantine, antidepressants, antipsychotics, mood stabilizers, benzodiazepines) for at least 30 days before baseline.
Key exclusion criteria (7 listed)
- History of stroke or other neurological or psychiatric disorder (other than FTD) that is considered the primary cause of behavioral symptoms.
- Pregnancy or breastfeeding, or plan to become pregnant during the study period.
- Use of any investigational or experimental drug or device within 60 days or 5 half-lives (whichever is longer) prior to screening.
- Presence of speech or language impairment that severely affects the implementation of neuropsychological assessments or safety evaluations per the study protocol.
- History of cancer, unless: (a) considered cured; (b) not actively receiving anti-cancer therapy or radiation and the investigator judges that treatment is unlikely to be needed in the next 5 years; or (c) for prostate cancer or basal cell carcinoma, no significant progression in the past 2 years.
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 |
|---|---|---|
| Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （Low-Dose）Participants randomized to the low-dose group will receive intranasal spray of human umbilical cord mesenchymal stem cell-derived exosomes (MSC-Exos), 1 mL per administration containing 24 × 10⁹ particles, twice weekly for 24 consecutive weeks. | Biological | Low-Dose Exosome Group |
| Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （High-Dose）Participants randomized to the high-dose group will receive intranasal spray of human umbilical cord mesenchymal stem cell-derived exosomes (MSC-Exos), 1 mL per administration containing 36 × 10⁹ particles, twice weekly for 24 consecutive weeks. Enrollment in this arm will only begin after the first 3 participants in the low-dose arm complete the 4-week safety lead-in period without dose-limiting toxicity or serious adverse events. | Biological | High-Dose MSC-Exosome |
| Placebo Comparator (0.9% NaCl)Participants randomized to the placebo group will receive intranasal spray of normal saline (0.9% sodium chloride), 1 mL per administration, twice weekly for 24 consecutive weeks. The placebo is identical in appearance, packaging, and administration procedure to the active investigational product to maintain blinding. | Other | Placebo Comparator |
Primary outcome
Clinical Efficacy: Change in CDR plus NACC FTLD Score
Time frame: Baseline and Week 24
Change from baseline in the Clinical Dementia Rating (CDR®) Dementia Staging Instrument plus the National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration (NACC FTLD) module total score at Week 24. Scale Range: Minimum = 0, Maximum = 30 Interpretation: A higher score indicates worse cognitive and behavioral function; a decrease (negative change) from baseline indicates improvement.
Safety and Tolerability: Incidence of Adverse Events
Time frame: Baseline through Week 24 (end of treatment)
Number of participants with treatment-emergent adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious adverse drug reactions (SADR), including assessment of causality and severity. Adverse events include local nasal reactions (e.g., epistaxis, nasal congestion, rhinorrhea, cough, pharyngeal discomfort, sneezing, nasal dryness) and systemic reactions (e.g., rash, pruritus, facial/eyelid swelling, dyspnea, chest tightness, fever, chills). Severity graded as mild, moderate, or severe.
8 secondary outcomes
Change in Global Cognition: MMSE Score
Time frame: Baseline, Week 12, Week 24
Change in Global Cognition: MoCA Score
Time frame: Baseline, Week 12, Week 24
Change in Language Function: BNT Score
Time frame: Baseline, Week 12, Week 24
Change in Language Function: Semantic Fluency Test
Time frame: Baseline, Week 12, Week 24
Change in Neuropsychiatric Symptoms: NPI Score
Time frame: Baseline, Week 12, Week 24
Change in Neuropsychiatric Symptoms: FBI Score
Time frame: Baseline, Week 12, Week 24
Change in Executive Function: FAB Score
Time frame: Baseline, Week 12, Week 24
Change in Daily Function and Behavior: ADL Score
Time frame: Baseline, Week 12, Week 24
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 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Shengdi Chen, MD, Ph.D principal investigator
Department of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （Low-Dose） and Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes （High-Dose） in people with Frontotemporal Dementia, run by Ruijin Hospital.
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 7 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: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Chao Gao, MD，Ph.D (+8618217590273, anshangaochao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Efficacy: Change in CDR plus NACC FTLD Score (time frame: Baseline and Week 24). 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 13 Jul 2026.