ClinicalTrials.gg
RecruitingNCT07514923SPRITE-CUpdated Sep 9, 2026

The Study of Safety and Preliminary Efficacy of ALT001 in Patients With MultIple System Atrophy-Cerebellar Type

An Early Phase 1 interventional study of ALT001 in Multiple System Atrophy - Cerebellar Subtype (MSA-C), sponsored by yilong Wang. Recruiting at 2 sites in China. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by yilong Wang · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study summary

This is a single-center, prospective, randomized, open-label, blinded outcome assessment (PROBE) study. At the end of the PROBE study, patients who have completed the study may opt to enter the open-label extension (OLE) study. The objective of the study is to evaluate the safety, tolerability and potential preliminary efficacy of ALT001 in the treatment of patients with multiple system atrophy-cerebellar type (MSA-C).

Read the detailed description

Multiple system atrophy (MSA) is a progressive neurodegenerative disorder characterized by a blend of autonomic dysfunction, Parkinson's syndrome, and cerebellar syndrome. The incidence of MSA ranges from 1.9 to 4.9 per 100,000 individuals, with an average age of onset of 56.2 years. Among individuals aged 50 years and older, the prevalence stands at 3.0 per 100,000. The mean age of MSA onset is 56.2 years, and the median survival ranges from 6.2 to 7.5 years. The MSA-C subtype is associated with a poorer prognosis due to its predominant involvement of the cerebellum and brainstem. In patients with MSA-C, gait and balance disturbances manifest early, leading to nearly 50% of patients requiring a walking aid or physical assistance for ambulation within three years of motor symptom onset. Within five years, 60% of patients become wheelchair-dependent, and after six to eight years, most are completely bedridden, severely impacting their quality of life. Treating MSA-C, a rare neurodegenerative condition, remains a significant challenge. Current symptomatic and supportive therapies fall short of meeting the treatment requirements of MSA-C patients. Furthermore, potential adverse effects and disease progression factors restrict the use of certain drugs, highlighting the critical need for the development of disease-modifying or neuroprotective agents to decelerate disease advancement. "ALT001, a nerve repair protein created by Darwin Origin (Hubei) Biopharmaceutical Co.LTD, is derived from cellular exosomes, a set of specific microenvironmental protein polymers secreted by stem cells under emergency conditions. It boasts selective assembly, targeted delivery, highly efficient tissue repair, exceptional safety, chemical stability, and convenient storage. Previous basic research has indicated ALT001's potential for promoting endogenous neural tissue repair, exhibiting significant neuroprotective and neurorestorative effects in animal models. Therefore, building upon the ongoing study in patients with the MSA-parkinsonian subtype, this project further initiates a single-center, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) study, followed by an open-label extension (OLE) study, specifically targeting patients with the MSA-C subtype. The objectives are to evaluate the safety, tolerability, and potential preliminary efficacy of ALT001 in treating MSA-C patients. This study aims to recruit 20 MSA-C subtype patients aged between 30 and 75 years. The visit content at each stage of this study includes vital signs, neurological examination, laboratory tests (such as routine blood test, blood biochemical examination, coagulation test, etc.), imaging examinations (such as MRI, bladder ultrasound), neurological assessments (such as unified multiple system atrophy rating scale [UMSARS], composite autonomic symptom score [COMPASS], scale for the assessment and rating of ataxia[SARA], quick MSA quality of life questionnaire [MSA-QoL], mini-mental state examination [MMSE]), and cerebrospinal fluid collection. Different stages of the study focus on monitoring patients' concomitant medications, adverse events, and serious adverse events. Detailed follow-up is conducted at the end of each treatment period, with face-to-face visits at specific time points. Additionally, researchers are required to promptly report and manage events when patients develop new neurological symptoms or suspicious events. The follow-up content of the study includes treatment and follow-up assessments at multiple stages. Initially, comprehensive physical examinations, laboratory tests (including blood, urine tests, etc.), multidimensional scoring assessments (such as UMSARS, COMPASS, SARA, MSA-QoL), and brain examinations through imaging techniques such as 3T MRI are performed on subjects at baseline. Subsequently, subjects enter three treatment periods and follow-up stages lasting a total of 90 days, with daily monitoring of vital signs, cerebrospinal fluid collection, laboratory tests, and adverse event documentation in each stage. Follow-up during the Open-Label Extension (OLE) phase (from day 90 to day 165 post-randomization) continues monitoring of vital signs, laboratory tests, and adverse event recording. At the follow-up visits on day 90, day 180, and day 360, comprehensive physical examinations, laboratory tests, gait analysis, bladder ultrasound, MRI, and repeat UMSARS, COMPASS, SARA, MSA-QoL scoring are conducted. Additionally, if patients experience new neurological symptoms or suspicious events, additional visits will be carried out, and researchers are required to submit and interpret relevant data within 72 hours of the event occurrence.The protocol of this study has been approved by the Ethics Committee of Beijing Tiantan Hospital. All participants will provide written informed consents before entering the study.

02

Conditions studied

  • Multiple System Atrophy - Cerebellar Subtype (MSA-C)

Keywords

  • Multiple system atrophy
03

In context

Multiple System Atrophy

207 studies on the registry are indexed under Multiple System Atrophy; 73 are open to participants now.

This study's planned enrollment of 20 is below the median of 41 across 134 interventional studies indexed under Multiple System Atrophy.

Browse Multiple System Atrophy studies →

Lead sponsor

yilong Wang is the lead sponsor of 7 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. Age between 30 and 75 years inclusive, either sex;
  • 2. Clinically established or clinically probable MSA-C as defined by the 2022 MDS diagnostic criteria for multiple system atrophy;
  • 3. Duration of MSA-C-related motor symptoms, including ataxia, no longer than 5 years;
  • 4. Score ≤ 3 on Item 14 of the Unified Multiple System Atrophy Rating Scale (UMSARS) Part II (motor examination);
  • 5. Estimated ≥ 1 year as assessed by the investigator;
  • 6. Voluntary participation in this study and provision of written

Exclusion criteria

Exclusion Criteria:

  • 1. Presence of other diseases that may cause ataxia at screening (e.g., infectious diseases, immune-mediated diseases, tumors, paraneoplastic conditions, hereditary disorders, trauma, nutritional deficiencies, toxic exposure, or other neurodegenerative diseases);
  • 2. Dementia indicated by the (MMSE) at enrollment (score ≤17 for illiterate individuals, ≤20 for primary school education, or ≤24 for junior high school or above) or a prior definitive diagnosis of dementia;
  • 3. Evidence of other central nervous system pathologies on brain MRI at screening suggesting a diagnosis of neurodegenerative diseases other than MSA; or other significant pathological findings on brain MRI at screening, including but not limited to: cerebral hemorrhage, acute cerebral infarction, aneurysm, vascular malformation, infectious lesions, brain tumors, or other space-occupying lesions (meningiomas or arachnoid cysts with a maximum diameter \<1 cm do not require exclusion);
  • 4. Presence of immune-mediated diseases that are inadequately controlled or require treatment with biologic agents;
  • 5. Known history of allergies to biologic agents, such as proteins or cell-based products;
  • 6. Receipt of any vaccination within the past 1 month;
  • 7. Patients with a prior definitive diagnosis of or those currently receiving anti-tumor drug therapy;
  • 8. Patients with a prior definitive diagnosis of epilepsy or those currently taking anti-epileptic drugs;
  • 9. Presence of lumbar spine diseases or deformities, or other to lumbar puncture;
  • 10. Coagulation abnormalities at enrollment (e.g., count \<100 × 10⁹/L; [PT] >3 seconds), a prior diagnosis of coagulation disorders such as hemophilia, or current use of two or more antiplatelet agents;
  • 11. Contraindications to MRI (e.g., claustrophobia, implanted cardiac pacemaker, or ferromagnetic metal);
  • 12. Concurrent severe hepatic insufficiency, renal insufficiency, or severe cardiac insufficiency (severe hepatic insufficiency defined as ≥1.5 times the or AST ≥1.5 times the upper limit of normal; severe renal insufficiency defined as serum creatinine [CRE] ≥1.5 times the upper limit of normal or estimated [eGFR] \<40 mL/min/1.73 m²; severe cardiac insufficiency defined as class 3-4), or any significant abnormalities on physical examination, vital signs, laboratory tests, or that, in the investigator's opinion, require further examination or treatment, or may interfere with the study procedures or safety;
  • 13. Active infection (positive for hepatitis B surface antigen, recurrent/persistent ALT elevation, positive serum HBV DNA, or serum HBV DNA >2 × 10⁵ IU/mL);
  • 14. Positive for virus antibody or a history of positive test results;
  • 15. Positive for or a history of positive test results;
  • 16. Patients with a history of alcohol or substance abuse, or alcohol or substance dependence within the past 2 years;
  • 17. Diagnosis of psychiatric disorders, severe anxiety, severe depression, or obvious suicidal ideation according to diagnostic criteria;
  • 18. Patients who are pregnant, lactating, or have the potential to become pregnant, or those planning a pregnancy;
  • 19. Current participation in other interventional trials or use of other biologic agents, drugs, or devices, or use of other investigational drugs within the past 1 month or within 5 half-lives of the drug;
  • 20. Inability to comply with follow-up assessments due to other reasons;
  • 21. Patients deemed by the investigator to be unsuitable for participation in this study.
Terms in these criteria, in plain language(17)

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

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.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

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.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Intrathecal administration combined with intravenous administration of ALT001 was given to each MSA patient in the intervention group, with intrathecal administration on days 1, 31 and 61 and intravenous administration on days 2 to 14, 32 to 44±3 and 62 to 74±5, and treatment was given once a day. intrathecal administration: 8 mL sodium chloride injection + ALT001 (130 μg/branch) for intrathecal administration, which was completed in about 5 minutes; intravenous administration: ALT001 (130 μg/branch) was dissolved in 100 ml sodium chloride injection, which was completed in about 30-40 minutes. After completion of the above treatments and 90±7 days of follow-up, all subjects entered the OLE study phase. During this period, all participants were given the option of continuing to receive 3 phases (on Days 91 to 104±7, Days 121 to 134±7, and Days 151 to 164±7) of intravenous ALT001 administration (14 consecutive days of ALT001 130 μg qd i.v. in each phase).

    Drug: ALT001

  • No intervention
    No intervention group

    Each MSA-C patient in the blank control group received only basic treatment with no trial-related treatment. After completion of the above treatments and 90±7 days of follow-up, all subjects entered the OLE study phase. During this period, all participants were given the option of continuing to receive 3 phases (on Days 91 to 104±7, Days 121 to 134±7, and Days 151 to 164±7) of intravenous ALT001 administration (14 consecutive days of ALT001 130 μg qd i.v. in each phase).

Interventions

  • DrugALT001

    Intrathecal administration combined with intravenous administration of ALT001 was given to each MSA patient in the intervention group, with intrathecal administration on days 1, 31 and 61 and intravenous administration on days 2 to 14, 32 to 44±3 and 62 to 74±5, and treatment was given once a day. intrathecal administration: 8 mL sodium chloride injection + ALT001 (130 μg/branch) for intrathecal administration, which was completed in about 5 minutes; intravenous administration: ALT001 (130 μg/branch) was dissolved in 100 ml sodium chloride injection, which was completed in about 30-40 minutes. After completion of the above treatments and 90±7 days of follow-up, all subjects entered the OLE study phase. During this period, all participants were given the option of continuing to receive 3 phases (on Days 91 to 104±7, Days 121 to 134±7, and Days 151 to 164±7) of intravenous ALT001 administration (14 consecutive days of ALT001 130 μg qd i.v. in each phase).

06

What researchers measure

Primary outcomes

  1. The incidence of investigator-reported adverse events (AEs) and serious adverse events (SAEs)

    The incidence of investigator-reported adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Day 90±7 after randomization

  2. The incidence of changes in clinical laboratory test parameters, changes in vital signs, neurological examination abnormalities and ECG abnormalities

    Laboratory tests include: routine blood test, coagulation test, blood biochemical examination, urinalysis (note that abnormal changes in laboratory test results may need to be reviewed to further determine and assess their relevance to the study). Vital signs include: abnormal body temperature (≥38℃ or ≤35℃), blood pressure (systolic blood pressure ≥180mmHg or \<90mmHg), respiration (\>24 beats/min and other rhythm abnormalities), and heart rate (\>100 beats/min or \<60 beats/min).

    Time frame: Day 90±7 after randomization

Secondary outcomes

  1. Changes in the unified multiple system atrophy rating scale (UMSARS) part scores, sum of part 1 and 2 scores

    The Unified Multiple System Atrophy Rating Scale (UMSARS) comprises four sections. Part I is the "Historical Review," consisting of 12 items that evaluate impairment in activities of daily living as reported by the patient. Each item is scored from a minimum of 0 points (normal) to a maximum of 4 points (severe disability), resulting in a total score range for this section of 0 to 48. Part II is the "Motor Examination," which assesses motor impairment based on clinical examination. It contains 14 items, each also scored from a minimum of 0 (normal) to a maximum of 4 (severe disability), yielding a total score range of 0 to 56. Part III is the "Autonomic Examination." Part IV is the "Global Disability Scale," a single-item scale used to assess the patient's overall level of disability, with scores ranging from a minimum of 1 (completely independent) to a maximum of 5 (totally bedridden).

    Time frame: Day 15, 45±3, 75±5, 90±7, 180±14, and 360±14 after randomization

  2. Changes in the scale for the assessment and rating of ataxia (SARA)

    The Scale for the Assessment and Rating of Ataxia (SARA) is a semi-quantitative clinical instrument designed to quantify the severity of cerebellar ataxia, with total scores ranging from 0 (no ataxia) to 40 (most severe ataxia). The scale comprises eight items that reflect progressively increasing functional impairment, assessing gait (0-8 points), stance (0-6 points), sitting (0-4 points), speech disturbance (0-6 points), finger chase (0-4 points), nose-finger test (0-4 points), fast alternating hand movements (0-4 points), and heel-knee-shin slide (0-4 points). For the upper and lower limb items, both sides are assessed separately, and the mean score is calculated for inclusion in the total score. SARA demonstrates good reliability and validity and is commonly used in clinical practice to evaluate the severity of ataxia and monitor disease progression.

    Time frame: Day 15, 45±3, 75±5, 90±7, 180±14, and 360±14 after randomization

  3. Changes in the composite autonomic symptom score (COMPASS) scores

    The Composite Autonomic Symptom Score (COMPASS) is a revised version of the 169-item Autonomic Symptom Profile assessing 11 domains of autonomic function, to the 31-item COMPASS, now assessing six domains: orthostatic hypotension (maximum score 10), vasomotor (maximum score 6), secretomotor (maximum score 7), gastrointestinal (maximum score 28), bladder (maximum score 9), and pupillomotor functions (maximum score 15). Scores from each component are recorded and a weighted total score is calculated. Higher scores on this scale indicate more severe clinical symptoms related to autonomic dysfunction. It is a validated, easy-to-use self-assessment instrument designed for clinical autonomic research and practice.

    Time frame: Day 15, 45±3, 75±5, 90±7, 180±14, and 360±14 after randomization

  4. Changes in the incidence of orthostatic hypotension

    Changes in the incidence of orthostatic hypotension in patients on days 15, 45±3, 75±5, 90±7, 180±14, and 360±14 after randomization as measured by recumbent-upright blood pressure monitoring/24-hour ambulatory blood pressure monitoring/head-upright tilt test.

    Time frame: Day 15, 45±3, 75±5, 90±7, 180±14, and 360±14 after randomization

  5. Changes in quick MSA quality of life questionnaire (MSA-QoL)

    The Quick MSA Quality of Life questionnaire (Quick MSA-QoL) is a concise, patient-reported outcome measure derived and validated from the original 40-item MSA-QoL scale. It is designed to reduce the completion burden for patients with multiple system atrophy (MSA) while enhancing data quality. This unidimensional scale comprises 15 items covering core domains, including motor function, non-motor symptoms, and emotional/social functioning. Each item offers five response options: no problem, mild problem, moderate problem, severe problem, and extreme problem. The total score of the scale ranges from 0 (minimum) to 60 (maximum). A higher total score indicates greater impairment in health-related quality of life.

    Time frame: Day 90±7, 180±14, and 360±14 after randomization

  6. Changes in immunological indices (lymphocyte subpopulation)

    Changes in immunological indices (lymphocyte subpopulation) on days 15, 30±3, 45±3, 60±5, 75±5, 105±7, 135±7, and 165±7 after randomization. Lymphocyte subsets include CD3+%, CD3+CD4+%, and CD3+CD8+%, among others.

    Time frame: Day 15, 30±3, 45±3, 60±5, 75±5, 105±7, 135±7, and 165±7 after randomization

  7. Variation of three-dimensional gait analysis parameters under multitasking

    Changes in three-dimensional gait analysis parameters under multitasking in patients on day 90±7, 180±14, and 360±14 after randomization. The main content of three-dimensional gait analysis is gait speed (m/s). The gait speed of participants was measured using a three-dimensional gait analyzer at various follow-up time points.

    Time frame: Day 90±7, 180±14, and 360±14 after randomization

Other outcomes

  1. Changes in postvoid residual urine volume (bladder ultrasound)

    Changes in postvoid residual urine volume (ml) (bladder ultrasound) in patients on day 90±7, 180±14, and 360±14 after randomization

    Time frame: Day 90±7, 180±14, and 360±14 after randomization

  2. Changes in plasma biomarkers (NFL, α-syn, GFAP)

    Changes in NFL (pg/ml), α-syn (pg/ml), GFAP (pg/ml) in plasma on days 15, 30±3, 60±5, 90±7, 180±14, and 360±14 after randomization. NFL (Neurofilament Light Chain) is a marker of axonal injury, reflecting the degree of neurodegeneration. α-syn (α-Synuclein) is a pathological hallmark protein in synucleinopathies like Parkinson's disease. GFAP (Glial Fibrillary Acidic Protein) indicates astroglial activation, suggesting CNS damage or inflammation.

    Time frame: Day 15, 30±3, 60±5, 90±7, 180±14, and 360±14 after randomization

  3. Changes in cerebrospinal fluid biomarkers (α-Syn SAA, NFL, α-syn, GFAP)

    Changes in α-Syn SAA, NFL (pg/ml), α-syn (pg/ml), GFAP (pg/ml) in cerebrospinal fluid on days 31±3 and 61±5 after randomization. α-Syn SAA enables ultrasensitive quantification of α-synuclein for early diagnosis of synucleinopathies. NFL is a marker of axonal injury, indicating neurodegeneration severity. α-syn is the pathological hallmark protein in synucleinopathies. GFAP indicates astroglial activation, reflecting CNS damage or inflammation.

    Time frame: Day 31±3 and 61±5 after randomization

  4. Changes in 3T MRI imaging features

    Longitudinal change rate of pontine volume (or AP diameter); longitudinal change rate of middle cerebellar peduncle (MCP) volume (or transverse diameter); longitudinal change rate of cerebellar white matter volume.

    Time frame: Day 90±7 after randomization

  5. Changes in fMRI (BOLD)

    Changes in fMRI (BOLD) on days 90±7 after randomization. Main indice of resting-state BOLD is ALFF. ALFF reflects the intensity of spontaneous neural activity in local brain regions. Higher ALFF values indicate more vigorous spontaneous neural activity in the corresponding brain region at rest; conversely, lower ALFF values suggest relatively reduced neural activity in that region.

    Time frame: Day 90±7 after randomization

  6. Changes in the incidence of investigator-reported adverse events (AEs) and serious adverse events (SAEs) within the group of patients who received the experimental treatment during the OLE study period

    Changes in the incidence of investigator-reported AEs and SAEs within the group of patients who received the experimental treatment during the OLE study period, as well as the incidence of investigator-reported AEs and SAEs between the groups of patients who received the experimental treatment and those who did not.

    Time frame: Day 120±7, 150±7, 180±14, and 360±14after randomization

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07514923
Lead sponsor
yilong Wang
Responsible party
yilong Wang (Vice President of Beijing Tiantan Hospital, Beijing Tiantan Hospital) — Sponsor-investigator
First posted
Apr 7, 2026
Start date
Jun 10, 2026
Primary completion
Jan 31, 2027 (estimated)
Completion
Oct 30, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Weiqi Chen
Contact
weiqichen@aliyun.com
8615652813380
Yahui Zhu
Contact
8613439182912
Yilong Wang
principal investigator · Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Tao Feng
principal investigator · Beijing Tiantan Hospital, Capital Medical University, Beijing, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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