Subcortical Vascular DementiaNCT03906123
The Efficacy of DL-NBP in Patients With Mild Subcortical Ischemic Vascular Dementia
A study testing NBP in people with Subcortical Vascular Dementia and Cerebral Small Vessel Diseases, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
This is a 48-week, double-blind, randomized, placebo-controlled study. Sixty-four patients are randomly assigned to take NBP (600mg per day) or placebo for 48 weeks, with 32 patients in each treatment group. Anti-dementia treatment-naive patients meet the inclusion/exclusion criteria are enrolled. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Subcortical Vascular Dementia, Cerebral Small Vessel Diseases
- What is being tested?
- NBP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2017to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meet the criteria of major neurocognitive disorder in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- Patients aged with 50-80 years, years of education no less than 3, an MMSE range of 15~26, an MoCA < 26, an Hamilton Depression Scale (HAMD) < 17;
- The MRI (one research dedicated machine 3.0 T) features satisfy subcortical small vessel disease, including (1) multiple (>=3) supratentorial subcortical lacunes (3-20 mm in diameter), with/without white matter hyperintensities (WMH) of any degree; (2) moderate to severe WMH (score>= 2 according to the Fazekas rating scale in either periventricular region or deep white matter) with/without lacunes; (3) one or more strategically located subcortical small infarcts in the deep grey matters;
- Patients or legal representative should sign the informed consent and have a reliable caregiver.
Who cannot join
- Cognitive impairment caused by other central nervous system diseases, such as AD, dementia with Lewy body, frontal-temporal lobe degeneration, etc;
- Cognitive impairment due to other conditions, such as severe depression, vitamin B 12 deficiency, abnormal thyroid function, etc;
- Alcoholism, drug abuse or other conditions influenced the evaluation of cognition;
- Patients unable to undertake MRI assessment.
- Patients with a history of other severe disease such as epilepsy, myocardial infarction or heart failure will be excluded;
- Administration of other investigational drugs, psychotropic drugs, drugs with psychiatric side effects, and oral anticoagulants are not allowed
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medicial University General Hospital
Tianjin, Tianjin Municipality, 300052
Nan Zhang, MD, PhD, 8622 60119688, nkzhangnan@163.com
Nan Zhang, MD, PhD
About this study
Official title: The Efficacy of DL-3-n-butylphthalide (DL-NBP) on the Cognitive Function and Vascular Regulation in Patients With Mild Vascular Dementia (VaD) Caused by Subcortical Ischemic Vascular Disease (SIVD)
This is a 48-week, double-blind, randomized, placebo-controlled study. Sixty-four patients are randomly assigned to take NBP (600mg per day) or placebo for 48 weeks, with 32 patients in each treatment group. Anti-dementia treatment-naive patients meet the inclusion/exclusion criteria are enrolled.
Patients are assigned to NBP will take 200mg tid daily. Patients are visited at baseline, as well as 4, 12, 24, 36, 48weeks after baseline. Safety data is recorded until an additional 30 days after the last treatment (48 weeks).
Read more
The primary outcomes include cognitive function and activities of daily living (ADL). All subjects are assessed at baseline, 4w, 12w,24w, 36w intermittent visit and 48w endpoint with the Auditory Verbal Learning Test (AVLT), the Brief Visuospatial Memory Test-Revised (BVMT-R), the Symbol Digit Modalities Test (SDMT), the Trail Making Test-A/B (TMT-A/B), the Benton Judgment of Line Orientation (JLO), the verbal fluency test, the Boston Naming Test (BNT), the Controlled Oral Word Association Test (COWAT), the Stroop test, the Mini-Mental State Examination (MMSE), the Montreal Cognitive Assessment (MoCA) and the ADL. The secondary outcomes include the global function and behavioral and psychological symptoms of dementia (BPSD), which are evaluated with the Clinical Dementia Rating (CDR) and the Neuropsychiatric Inventory (NPI), respectively. Independent raters who are blinded to patients' distribution are assigned to assess the participants.
The exploratory outcomes are markers of vascular regulation, including circulating endothelial progenitor cells (EPCs), white matter hyperintensities (WMH) on MRI, cerebral blood flow (CBF) measured with transcranial Doppler (TCD) and arterial spin labeling (ASL) MRI, and parameters of carotid duplex ultrasonic (CDU). In addition, apolipoprotein E (APOE) polymorphism and plasma biomarkers are also detected.
Safety are assessed at each visit.
- Being tested
- NBP, Placebos
- Keywords
- DL-3-n-butylphthalide, vascular dementia, cerebral small vessel disease, cognitive function, cerebral blood flow
- Medical subject headings
- Dementia, Vascular, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBPDrug
Also called DL-3-n-butylphthalide
NBP soft capsules
PlacebosDrug
Soft capsules manufactured to mimic NBP
| Study group | Role | What they receive |
|---|---|---|
| NBP | Experimental | DL-3-n-butylphthalide (NBP), soft capsule, 200mg Tid, po, for 48 weeks. Receives: Drug: NBP |
| Placebos | Placebo comparator | Placebo, soft capsule, 200mg Tid, po, for 48 weeks. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auditory Verbal Learning Test (AVLT) at endpoint and change from baseline
AVLT is used to evaluate verbal learning and memory ability. Higher score indicates better performance.
Measured: 48 weeks post-dose and change from baseline
Brief Visuospatial Memory Test-Revised (BVMT-R) at endpoint and change from baseline
BVMT-R is used to evaluate spatial memory ability. Higher score indicates better performance.
Measured: 48 weeks post-dose and change from baseline
Digital span (DS) at endpoint and change from baseline
DS is used to assess attention. Higher score indicates better performance.
Measured: 48 weeks post-dose and change from baseline
Symbol Digit Modalities Test (SDMT) at endpoint and change from baseline
SDMT is used to assess information processing speed. Higher score indicates better performance.
Measured: 48 weeks post-dose and change from baseline
Trail Making Test-A (TMT-A) at endpoint and change from baseline
TMT-A is used to assess information processing speed. Lower score indicates better performance.
Measured: 48 weeks post-dose and change from baseline
TMT-B at endpoint and change from baseline
TMT-B is used to assess executive function. Lower score indicates better performance.
Measured: 48 weeks post-dose and change from baseline
Stroop test at endpoint and change from baseline
Stroop test is used to assess executive function. Higher score indicates better performance.
Measured: 48 weeks post-dose and change from baseline
Benton Judgment of Line Orientation (JLO) at endpoint and change from baseline
JLO is used to assess visuospatial function. Higher score indicates better performance.
Measured: 48 weeks post-dose and change from baseline
Verbal fluency test at endpoint and change from baseline
Verbal fluency test is used to evaluate language function. Higher score indicates better performance.
Measured: 48 weeks post-dose and change from baseline
Boston Naming Test (BNT) at endpoint and change from baseline
BNT is used to evaluate language function. Higher score indicates better performance.
Measured: 48 weeks post-dose and change from baseline
Controlled Oral Word Association Test (COWAT) at endpoint and change from baseline
COWAT is used to evaluate language function. Higher score indicates better performance.
Measured: 48 weeks post-dose and change from baseline
Mini-Mental State Examination (MMSE) at endpoint and change from baseline
MMSE is used to evaluate global cognition. Higher score indicates better performance.
Measured: 48 weeks post-dose and change from baseline
Montreal Cognitive Assessment (MoCA) at endpoint and change from baseline
MoCA is used to evaluate global cognition. Higher score indicates better performance.
Measured: 48 weeks post-dose and change from baseline
Activity of daily living (ADL) at endpoint and change from baseline
ADL is used to evaluate activities of daily living.
Measured: 48 weeks post-dose and change from baseline
Secondary outcomes (2)
Global function at endpoint and change from baseline
Clinical Dementia Rating (CDR) is used to evaluate global function.
Measured: 48 weeks post-dose and change from baseline
Neuropsychiatric Inventory (NPI) at endpoint and change from baseline
NPI is used to evaluate behavioral and psychological symptoms of dementia (BPSD).
Measured: 48 weeks post-dose and change from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start18 Nov 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subcortical Vascular DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, randomized, placebo controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nan Zhang, MD, PhD, Tianjin Medical University General Hospital
- Investigators
- Nan Zhang, MD, PhD, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906123
- Sponsor's protocol ID
- TianjinMUGH001
- Status last verified
- Apr 2019
- First submitted
- 27 Mar 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be available
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of DL-3-n-butylphthalide (DL-NBP) on the Cognitive Function and Vascular Regulation in Patients With Mild Vascular Dementia (VaD) Caused by Subcortical Ischemic Vascular Disease (SIVD)
- ClinicalTrials.gov ID
- NCT03906123
- Acronym / sponsor ID
- TianjinMUGH001
- Keywords
- DL-3-n-butylphthalide, vascular dementia, cerebral small vessel disease, cognitive function, cerebral blood flow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 18 Nov 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 8 Apr 2019 (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 is a 48-week, double-blind, randomized, placebo-controlled study. Sixty-four patients are randomly assigned to take NBP (600mg per day) or placebo for 48 weeks, with 32 patients in each treatment group. Anti-dementia treatment-naive patients meet the inclusion/exclusion criteria are enrolled.
Patients are assigned to NBP will take 200mg tid daily. Patients are visited at baseline, as well as 4, 12, 24, 36, 48weeks after baseline. Safety data is recorded until an additional 30 days after the last treatment (48 weeks).
The primary outcomes include cognitive function and activities of daily living (ADL). All subjects are assessed at baseline, 4w, 12w,24w, 36w intermittent visit and 48w endpoint with the Auditory Verbal Learning Test (AVLT), the Brief Visuospatial Memory Test-Revised (BVMT-R), the Symbol Digit Modalities Test (SDMT), the Trail Making Test-A/B (TMT-A/B), the Benton Judgment of Line Orientation (JLO), the verbal fluency test, the Boston Naming Test (BNT), the Controlled Oral Word Association Test (COWAT), the Stroop test, the Mini-Mental State Examination (MMSE), the Montreal Cognitive Assessment (MoCA) and the ADL. The secondary outcomes include the global function and behavioral and psychological symptoms of dementia (BPSD), which are evaluated with the Clinical Dementia Rating (CDR) and the Neuropsychiatric Inventory (NPI), respectively. Independent raters who are blinded to patients' distribution are assigned to assess the participants.
The exploratory outcomes are markers of vascular regulation, including circulating endothelial progenitor cells (EPCs), white matter hyperintensities (WMH) on MRI, cerebral blood flow (CBF) measured with transcranial Doppler (TCD) and arterial spin labeling (ASL) MRI, and parameters of carotid duplex ultrasonic (CDU). In addition, apolipoprotein E (APOE) polymorphism and plasma biomarkers are also detected.
Safety are assessed at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind, randomized, placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| NBP | Experimental | Drug: NBPDL-3-n-butylphthalide (NBP), soft capsule, 200mg Tid, po, for 48 weeks. |
| Placebos | Placebo comparator | Drug: PlacebosPlacebo, soft capsule, 200mg Tid, po, for 48 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients meet the criteria of major neurocognitive disorder in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- Patients aged with 50-80 years, years of education no less than 3, an MMSE range of 15~26, an MoCA < 26, an Hamilton Depression Scale (HAMD) < 17;
- The MRI (one research dedicated machine 3.0 T) features satisfy subcortical small vessel disease, including (1) multiple (>=3) supratentorial subcortical lacunes (3-20 mm in diameter), with/without white matter hyperintensities (WMH) of any degree; (2) moderate to severe WMH (score>= 2 according to the Fazekas rating scale in either periventricular region or deep white matter) with/without lacunes; (3) one or more strategically located subcortical small infarcts in the deep grey matters;
- Patients or legal representative should sign the informed consent and have a reliable caregiver.
Key exclusion criteria (6 listed)
- Cognitive impairment caused by other central nervous system diseases, such as AD, dementia with Lewy body, frontal-temporal lobe degeneration, etc;
- Cognitive impairment due to other conditions, such as severe depression, vitamin B 12 deficiency, abnormal thyroid function, etc;
- Alcoholism, drug abuse or other conditions influenced the evaluation of cognition;
- Patients unable to undertake MRI assessment.
- Patients with a history of other severe disease such as epilepsy, myocardial infarction or heart failure will be excluded;
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 |
|---|---|---|
| NBPAlso: DL-3-n-butylphthalideNBP soft capsules | Drug | NBP |
| PlacebosSoft capsules manufactured to mimic NBP | Drug | Placebos |
Primary outcome
Auditory Verbal Learning Test (AVLT) at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
AVLT is used to evaluate verbal learning and memory ability. Higher score indicates better performance.
Brief Visuospatial Memory Test-Revised (BVMT-R) at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
BVMT-R is used to evaluate spatial memory ability. Higher score indicates better performance.
Digital span (DS) at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
DS is used to assess attention. Higher score indicates better performance.
Symbol Digit Modalities Test (SDMT) at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
SDMT is used to assess information processing speed. Higher score indicates better performance.
Trail Making Test-A (TMT-A) at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
TMT-A is used to assess information processing speed. Lower score indicates better performance.
TMT-B at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
TMT-B is used to assess executive function. Lower score indicates better performance.
Stroop test at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
Stroop test is used to assess executive function. Higher score indicates better performance.
Benton Judgment of Line Orientation (JLO) at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
JLO is used to assess visuospatial function. Higher score indicates better performance.
Verbal fluency test at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
Verbal fluency test is used to evaluate language function. Higher score indicates better performance.
Boston Naming Test (BNT) at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
BNT is used to evaluate language function. Higher score indicates better performance.
Controlled Oral Word Association Test (COWAT) at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
COWAT is used to evaluate language function. Higher score indicates better performance.
Mini-Mental State Examination (MMSE) at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
MMSE is used to evaluate global cognition. Higher score indicates better performance.
Montreal Cognitive Assessment (MoCA) at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
MoCA is used to evaluate global cognition. Higher score indicates better performance.
Activity of daily living (ADL) at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
ADL is used to evaluate activities of daily living.
2 secondary outcomes
Global function at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
Neuropsychiatric Inventory (NPI) at endpoint and change from baseline
Time frame: 48 weeks post-dose and change from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be available
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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. This study is not recruiting at the moment.
Nan Zhang, MD, PhD principal investigator
Tianjin Medical University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NBP in people with Subcortical Vascular Dementia and Cerebral Small Vessel Diseases, run by Tianjin Medical University General 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Apr 2019. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nan Zhang, MD, PhD (+8622 60119688, nkzhangnan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory Verbal Learning Test (AVLT) at endpoint and change from baseline (time frame: 48 weeks post-dose and change from baseline). The study lists 14 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 8 Apr 2019.