A Phase 3 interventional study of Minocycline and Minocycline placebo in Neurosyphilis, sponsored by Beijing Ditan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Beijing Ditan Hospital · Phase 3, Interventional, and Treatment
Study Objective: Neurosyphilis remains a major clinical challenge: despite standard first-line therapy with intravenous penicillin G, as recommended by international and Chinese guidelines, approximately 30% of patients have residual neurological impairment. Minocycline, a tetracycline antibiotic, has both anti-Treponema pallidum activity and independent anti-inflammatory and neuroprotective effects. We therefore designed a prospective, multicenter, randomized, double-blind, placebo-controlled trial to evaluate whether the addition of minocycline to penicillin, as compared with penicillin monotherapy, improves the 6-month rate of favorable neurological outcomes in patients with neurosyphilis. This trial will provide evidence-based evidence for the treatment of neurosyphilis. Inclusion Criteria: 1）Age 18-80 years; 2）Diagnosis of neurosyphilis according to the Guidelines for the Diagnosis and Treatment of Syphilis, Gonorrhea and Genital Chlamydia trachomatis Infection (2020); 3）Cognitive impairment (MMSE score 10-26) or ischemic stroke-like episodes (time from onset to randomization ≤14 days, NIHSS score 1-20); 4）Written informed consent provided by the patient or their legally authorized representative. Intervention: Participants will be randomly assigned ( by chance ) to one of two groups. Group 1 will receive standard intravenous penicillin therapy plus oral minocycline for 28 days. Group 2 will receive standard intravenous penicillin therapy plus oral placebo for 28 days. All participants will receive standard penicillin treatment. Participants and their doctors will not know which group they are in. Follow-up: Participants will be followed for up to 12 months, with five follow-up visits: baseline (before treatment initiation), end of intravenous penicillin treatment (Day 12 ± 2 days), end of minocycline treatment (Day 28 + 2 days), 6 months post-treatment (Month 6 ± 7 days), and 12 months post-treatment (Month 12 ± 7 days). Assessments will include standardized neurological function scales for favorable neurological outcomes, cognitive function, neurological deficits, and activities of daily living; cerebrospinal fluid and serum efficacy marker testing; and brain MRI.
Potential Benefits and Risks: Participants may or may not benefit from participating in this study. All participants will receive standard treatment for neurosyphilis. The main risks are complications that may occur during study procedures (such as lumbar puncture, or allergic reactions to penicillin) and possible side effects of minocycline, including dizziness, vestibular side effects, nausea, or skin sensitivity to sunlight. The study team will closely monitor participants for any adverse reactions. Importance of This Study: If minocycline does help improve neurological outcomes, it could become a new treatment option for patients with neurosyphilis, thereby helping to reduce the occurrence of neurological sequelae. The implementation of this study will provide evidence-based evidence for the treatment of neurosyphilis.
Beijing Ditan Hospital is the lead sponsor of 53 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive standard intravenous aqueous crystalline penicillin G (18-24 million units/day for 10-14 days) plus oral minocycline (200 mg loading dose on Day 1, followed by 100 mg every 12 hours) for 28 days.
Drug: Minocycline · Drug: Aqueous crystalline penicillin G
Participants will receive standard intravenous aqueous crystalline penicillin G (18-24 million units/day for 10-14 days) plus oral matching minocycline placebo (200 mg loading dose on Day 1, followed by 100 mg every 12 hours) for 28 days.
Drug: Minocycline placebo · Drug: Aqueous crystalline penicillin G
Administered orally. Loading dose of 200 mg on Day 1, followed by 100 mg every 12 hours for 28 days. Given only to participants in the Experimental Group.
Oral matching placebo to minocycline. Loading dose of 200 mg on Day 1, followed by 100 mg every 12 hours for 28 days. Given only to participants in the Control Group.
Administered intravenously at 18-24 million units per day for 10-14 days. Given to all participants in both arms.
Proportion of participants with favorable neurological outcomes at 6 months
Unit of measure: Percentage (%). A favorable neurological outcome is defined as meeting both of the following criteria: (1) a modified Rankin Scale score of 0 to 2, AND (2) at least one of the following: an improvement in the Mini-Mental State Examination score of ≥2 points from baseline, or a Mini-Mental State Examination score of \>26. The Mini-Mental State Examination score ranges from 0 to 30, with higher scores indicating better cognitive function. The modified Rankin Scale score ranges from 0 to 6, with higher scores indicating worse disability.
Time frame: At 6 months post-treatment
Proportion of participants with normal cerebrospinal fluid (CSF) white blood cell counts
Unit of measure: Percentage (%). The proportion of participants with normal cerebrospinal fluid (CSF) white blood cell counts (≤5 cells/μL; or ≤20 cells/μL for participants with HIV) at 6 months, as measured by CSF analysis.
Time frame: At 6 months post-treatment
Proportion of participants with normal cerebrospinal fluid (CSF) protein levels
Unit of measure: Percentage (%). The proportion of participants with normal cerebrospinal fluid (CSF) protein levels (\<500 mg/L) at 6 months post-treatment, as measured by CSF biochemical analysis.
Time frame: At 6 months post-treatment
Proportion of participants with a ≥4-fold decline or seroreversion in cerebrospinal fluid (CSF) non-treponemal antibody titers
Unit of measure: Percentage (%). The proportion of participants with a ≥4-fold decline or seroreversion in cerebrospinal fluid (CSF) non-treponemal antibody titers. Titers are measured by Venereal Disease Research Laboratory (VDRL), toluidine red unheated serum test (TRUST), or rapid plasma reagin (RPR) tests on CSF samples. Notably, titer assessments must use the same assay method as the baseline measurement; results from different methods are not comparable.
Time frame: At 6 months post-treatment
Proportion of participants with a ≥4-fold decline or seroreversion in serum non-treponemal antibody titers
Unit of measure: Percentage (%). The proportion of participants with a ≥4-fold decline or seroreversion in serum non-treponemal antibody titers, measured by toluidine red unheated serum test (TRUST) or rapid plasma reagin (RPR) tests on serum samples. Notably, titer assessments must use the same assay method as the baseline measurement; results from different methods are not comparable.
Time frame: At 6 months post-treatment
Proportion of participants with a modified Rankin Scale (mRS) score of 0 to 2
Unit of measure: Percentage (%). The proportion of participants with a modified Rankin Scale (mRS) score of 0 to 2 at 6 months post-treatment. The mRS is a 7-point scale ranging from 0 to 6, where a score of 0 indicates no symptoms and a score of 6 indicates death. A score of 0 to 2 indicates functional independence (a favorable outcome). Higher scores indicate worse disability.
Time frame: At 6 months post-treatment
Proportion of participants with a ≥2-point improvement or a score >26 in the Mini-Mental State Examination
Unit of measure: Percentage (%). The proportion of participants meeting at least one of the following criteria at 6 months: (1) an improvement of ≥2 points from baseline in the Mini-Mental State Examination (MMSE) score, or (2) an MMSE score of \>26. The MMSE is a 30-point questionnaire ranging from 0 to 30, where higher scores indicate better cognitive function.
Time frame: At 6 months post-treatment
Change from baseline in the modified Rankin Scale (mRS) score at 6 months
Unit of measure: Points. The change in the modified Rankin Scale (mRS) score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The mRS is a 7-point scale ranging from 0 to 6, where a score of 0 indicates no symptoms and 6 indicates death. Higher scores indicate worse disability. A negative value indicates an improvement (reduction in disability) from baseline.
Time frame: At 6 months post-treatment
Change from baseline in the Mini-Mental State Examination (MMSE) score at 6 months
Unit of measure: Points. The change in the MMSE score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The MMSE ranges from 0 to 30, with higher scores indicating better cognitive function. A negative value indicates cognitive decline.
Time frame: At 6 months post-treatment
Change from baseline in the Montreal Cognitive Assessment (MoCA) Beijing version score at 6 months
Unit of measure: Points. The change in the Montreal Cognitive Assessment (MoCA) Beijing version score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The MoCA Beijing version ranges from 0 to 30, with higher scores indicating better cognitive function. A negative value indicates cognitive decline.
Time frame: At 6 months post-treatment
Change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score at 6 months
Unit of measure: Points. The change in the NIHSS score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological deficits. A negative value indicates neurological improvement.
Time frame: At 6 months post-treatment
Change from baseline in the Lawton Activities of Daily Living Scale (Chinese 14-item revised version) score at 6 months
Unit of measure: Points. The change in the Lawton Activities of Daily Living Scale score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). Based on the framework of Lawton \& Brody (1969), this 14-item Chinese revised version includes 6 basic ADL and 8 instrumental ADL items. Each item is scored from 1 to 4, yielding a total score ranging from 14 to 56, with higher scores indicating worse function. A negative value indicates an improvement in daily function.
Time frame: At 6 months post-treatment
Change from baseline in the Beck Depression Inventory-II (BDI-II) score at 6 months
Unit of measure: Points. The change in the BDI-II score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The BDI-II ranges from 0 to 63, with higher scores indicating more severe depressive symptoms. A negative value indicates an improvement in depressive symptoms.
Time frame: At 6 months post-treatment
Change from baseline in the Neuropsychiatric Inventory (NPI) score at 6 months
Unit of measure: Points. The change in the NPI score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The NPI total score ranges from 0 to 144, with higher scores indicating more severe neuropsychiatric symptoms. A negative value indicates an improvement in neuropsychiatric symptoms.
Time frame: At 6 months post-treatment
Change from baseline in the Global Cortical Atrophy (GCA) total score at 6 months
Unit of measure: Points. The change in the Global Cortical Atrophy (GCA) total score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The GCA scale assesses cortical atrophy on cranial MRI by evaluating three regions: the frontal, parietal, and temporal lobes. Each of the three regions is scored from 0 to 3 (where 0 = no atrophy and 3 = severe atrophy). The total GCA score is the sum of the scores for these three regions, ranging from 0 to 9, with higher scores indicating more severe brain atrophy. A positive value indicates progression of brain atrophy.
Time frame: At 6 months post-treatment
Change from baseline in total brain lesion volume on Magnetic Resonance Imaging (MRI) at 6 months
Unit of measure: Cubic millimeters (mm³). The change in the total volume of brain lesions from baseline to 6 months post-treatment (calculated as the 6-month volume minus the baseline volume). The lesion volume is measured using T2-weighted or FLAIR sequences on cranial MRI. A positive value indicates an increase in lesion volume (worsening).
Time frame: At 6 months post-treatment
All-cause mortality at 6 months
Unit of measure: Count (number of participants). The number of participants who died from any cause during the 6-month period post-treatment.
Time frame: Up to 6 months post-treatment
Number of participants with adverse events (AEs) at 6 months
Unit of measure: Count (number of participants). The number of participants who experienced at least one adverse event (AE) from baseline to 6 months post-treatment. Adverse events are assessed and graded according to standard clinical safety criteria.
Time frame: Up to 6 months post-treatment
Number of participants with serious adverse events (SAEs) at 6 months
Unit of measure: Count (number of participants). The number of participants who experienced at least one serious adverse event (SAE) from baseline to 6 months post-treatment. SAEs are assessed and graded according to standard clinical safety criteria.
Time frame: Up to 6 months post-treatment
Change from baseline in the modified Rankin Scale (mRS) score at the end of intravenous penicillin treatment
Unit of measure: Points. The change in the mRS score from baseline to the end of intravenous penicillin treatment (calculated as the end-of-treatment score minus the baseline score). The mRS is a 7-point scale ranging from 0 to 6, with higher scores indicating worse disability. A negative value indicates an improvement in neurological function.
Time frame: At the end of intravenous penicillin treatment (Day 12 ± 2 days)
Change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score at the end of intravenous penicillin treatment
Unit of measure: Points. The change in the NIHSS score from baseline to the end of intravenous penicillin treatment (calculated as the end-of-treatment score minus the baseline score). The NIHSS is a 15-item scale ranging from 0 to 42, with higher scores indicating more severe neurological deficits. A negative value indicates an improvement in neurological function.
Time frame: At the end of intravenous penicillin treatment (Day 12 ± 2 days)
Proportion of participants with normal cerebrospinal fluid (CSF) white blood cell counts at 12 months
Unit of measure: Percentage (%). The proportion of participants with normal cerebrospinal fluid (CSF) white blood cell counts (≤5 cells/μL; or ≤20 cells/μL for participants with HIV) at 12 months post-treatment, as measured by CSF analysis.
Time frame: At 12 months post-treatment
Proportion of participants with normal cerebrospinal fluid (CSF) protein levels at 12 months
Unit of measure: Percentage (%). The proportion of participants with normal cerebrospinal fluid (CSF) protein levels (\<500 mg/L) at 12 months post-treatment, as measured by CSF biochemical analysis.
Time frame: At 12 months post-treatment
Proportion of participants with a ≥4-fold decline or seroreversion in cerebrospinal fluid (CSF) non-treponemal antibody titers at 12 months
Unit of measure: Percentage (%). The proportion of participants with a ≥4-fold decline or seroreversion in cerebrospinal fluid (CSF) non-treponemal antibody titers. Titers are measured by Venereal Disease Research Laboratory (VDRL), toluidine red unheated serum test (TRUST), or rapid plasma reagin (RPR) tests on CSF samples. Notably, titer assessments must use the same assay method as the baseline measurement; results from different methods are not comparable.
Time frame: At 12 months post-treatment
Proportion of participants with a ≥4-fold decline or seroreversion in serum non-treponemal antibody titers at 12 months
Unit of measure: Percentage (%). The proportion of participants with a ≥4-fold decline or seroreversion in serum non-treponemal antibody titers, measured by toluidine red unheated serum test (TRUST) or rapid plasma reagin (RPR) tests on serum samples. Notably, titer assessments must use the same assay method as the baseline measurement; results from different methods are not comparable.
Time frame: At 12 months post-treatment
Change from baseline in the modified Rankin Scale (mRS) score at 12 months
Unit of measure: Points. The change in the modified Rankin Scale (mRS) score from baseline to 12 months post-treatment (calculated as the 12-month score minus the baseline score). The mRS is a 7-point scale ranging from 0 to 6, where a score of 0 indicates no symptoms and 6 indicates death. Higher scores indicate worse disability. A negative value indicates an improvement (reduction in disability) from baseline.
Time frame: At 12 months post-treatment
Change from baseline in the Mini-Mental State Examination (MMSE) score at 12 months
Unit of measure: Points. The change in the MMSE score from baseline to 12 months post-treatment (calculated as the 12-month score minus the baseline score). The MMSE ranges from 0 to 30, with higher scores indicating better cognitive function. A negative value indicates cognitive decline.
Time frame: At 12 months post-treatment
Change from baseline in the Montreal Cognitive Assessment (MoCA) Beijing version score at 12 months
Unit of measure: Points. The change in the Montreal Cognitive Assessment (MoCA) Beijing version score from baseline to 12 months post-treatment (calculated as the 12-month score minus the baseline score). The MoCA Beijing version ranges from 0 to 30, with higher scores indicating better cognitive function. A negative value indicates cognitive decline.
Time frame: At 12 months post-treatment
Change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score at 12 months
Unit of measure: Points. The change in the NIHSS score from baseline to 12 months post-treatment (calculated as the 12-month score minus the baseline score). The NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological deficits. A negative value indicates neurological improvement.
Time frame: At 12 months post-treatment
Change from baseline in the Lawton Activities of Daily Living Scale (Chinese 14-item revised version) score at 12 months
Unit of measure: Points. The change in the Lawton Activities of Daily Living Scale score from baseline to 12 months post-treatment (calculated as the 12-month score minus the baseline score). Based on the framework of Lawton \& Brody (1969), this 14-item Chinese revised version includes 6 basic ADL and 8 instrumental ADL items. Each item is scored from 1 to 4, yielding a total score ranging from 14 to 56, with higher scores indicating worse function. A negative value indicates an improvement in daily function.
Time frame: At 12 months post-treatment
Change from baseline in the Beck Depression Inventory-II (BDI-II) score at 12 months
Unit of measure: Points. The change in the BDI-II score from baseline to 12 months post-treatment (calculated as the 12-month score minus the baseline score). The BDI-II ranges from 0 to 63, with higher scores indicating more severe depressive symptoms. A negative value indicates an improvement in depressive symptoms.
Time frame: At 12 months post-treatment
Change from baseline in the Neuropsychiatric Inventory (NPI) score at 12 months
Unit of measure: Points. The change in the NPI score from baseline to 12 months post-treatment (calculated as the 12-month score minus the baseline score). The NPI total score ranges from 0 to 144, with higher scores indicating more severe neuropsychiatric symptoms. A negative value indicates an improvement in neuropsychiatric symptoms.
Time frame: At 12 months post-treatment
Change from baseline in the Global Cortical Atrophy (GCA) total score at 12 months
Unit of measure: Points. The change in the Global Cortical Atrophy (GCA) total score from baseline to 12 months post-treatment (calculated as the 12-month score minus the baseline score). The GCA scale assesses cortical atrophy on cranial MRI by evaluating three regions: the frontal, parietal, and temporal lobes. Each of the three regions is scored from 0 to 3 (where 0 = no atrophy and 3 = severe atrophy). The total GCA score is the sum of the scores for these three regions, ranging from 0 to 9, with higher scores indicating more severe brain atrophy. A positive value indicates progression of brain atrophy.
Time frame: At 12 months post-treatment
Change from baseline in total brain lesion volume on Magnetic Resonance Imaging (MRI) at 12 months
Unit of measure: Cubic millimeters (mm³). The change in the total volume of brain lesions from baseline to 12 months post-treatment (calculated as the 12-month volume minus the baseline volume). The lesion volume is measured using T2-weighted or FLAIR sequences on cranial MRI. A positive value indicates an increase in lesion volume (worsening).
Time frame: At 12 months post-treatment
Plan to share: No — Individual participant data (IPD) will not be shared. The data collected in this study will be used solely by the study investigators for the purposes outlined in this protocol.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Minocycline
Neurosyphilis
Beijing Ditan Hospital