CerebrAlcare Pills on CereBral Small VesseL DiseasE（CABLE）

NCT05578521 | Unknown Phase 4 DMC

• 1 other identifier: KY-2021-176-04
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blinded, placebo-controlled, multicenter trial. Cerebral small vessel disease (CSVD) patients will be diagnosed by Magnetic Resonance Imaging (MRI) and randomized into treatment or control groups. The purpose of this trial is to assess the efficacy of cerebralcare pills on cerebral small vessel disease.

Conditions

Cerebral Small Vessel Diseases

Keywords

cerebral small vessel diseases; Cerebralcare Pills; cognitive function; randomized controlled trial; multicenter study; double blind study; placebo-controlled

Outcome Measures

Primary Outcomes (1)

• Progression in cognition function

  Cognition function assessed by Montreal Cognitive Assessment (MoCA) score. Score range 0-30. Higher scores mean a better outcome..

  6 months after randomization

Secondary Outcomes (23)

• Changes in both systolic and diastolic blood pressure

  3 months, 6 months and 1 year after randomization

• Rey auditory verbal learning test（RAVLT）

  3 months, 6 months and 1 year after randomization

• Generalized Anxiety Disorder 7（GAD-7)

  3 months, 6 months and 1 year after randomization

• Self-rating depression scale

  3 months, 6 months and 1 year after randomization

• Dizziness handicap inventory（DHI）

  3 months, 6 months and 1 year after randomization

Study Arms (2)

Cerebralcare pills placebo group

PLACEBO COMPARATOR

This group will receive Cerebralcare pills placebo, 2 packages, twice a day, from the day of randomization to 6 months.

Drug: Cerebralcare pills placebo

Cerebralcare pills group

EXPERIMENTAL

This group will receive Cerebralcare pills, 2 packages, twice a day, from the day of randomization to 6 months.

Drug: Cerebralcare pills

Interventions

Cerebralcare pills DRUG

a dose of 2 packages, twice a day of Cerebralcare pills

Cerebralcare pills group

Cerebralcare pills placebo DRUG

Cerebralcare pills placebo will be administrated at the same rate with experimental group

Cerebralcare pills placebo group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• No gender limitation;
• Cerebral small vessel disease is observed on brain MRI. White matter hyperintensity, Fazekas score ≥ 1 and combined more than 2 vascular risk factors (hypertension, hyperlipidemia, diabetes, obesity, smoking, and other vascular events except stroke) or combined with lacunar focus or Imaging findings suggest new subcortical lacunar infarction (within 7 days).
• Mild or moderate vascular cognitive impairment(16 ≤ MoCA ≤ 24 score, for patients with primary school degree or below,15 ≤ MoCA ≤ 23 score).
• Daily life independence (mRS ≤ 2).
• Sign informed consent.
• Note:
• The imaging definition of small vessel disease refers to the strong guideline The total score of Fazekas was 6, which was the sum of Fazekas scores of subcortical and periventricular white matter lesions.
• New subcortical lacunar infarction: head MRI examination, subcortical, basal ganglia or brain stem DWI showed high signal (ADC diffusion limited) lesions with diameter \< 20 mm, with or without corresponding clinical symptoms; There were new clinical symptoms. FLAIR sequence of head MRI showed flair hyperintense lesions (diameter \< 20 mm) in subcortical, basal ganglia or pons.

You may not qualify if:

• Cerebral hemorrhage and subarachnoid hemorrhage occurred within 30 days.
• Symptomatic middle cerebral artery and/or internal carotid artery stenosis, stenosis rate ≥ 50%; asymptomatic middle cerebral artery and/or internal carotid artery stenosis, stenosis rate ≥ 70%.
• Coronary CTA or coronary angiography showed severe three vessel lesions or frequent angina pectoris within 30 days.
• Chronic kidney disease stage 4 or 5.
• Resistant hypertension which could not be controlled by medicine (SBP \> 180mmHg or DBP \> 110mmHg).
• Resistant hyperglycemia which could not be controlled by medicine（fasting blood glucose \> 10mmol/L or HB1AC \> 7%).
• In acute cerebral infarction, the lesions showed high signal intensity on DWI, and the diameter was more than 20 mm or history of assive cerebral infarction within 30 days.
• Neurodegenerative diseases, such as AD and PD, have been diagnosed.
• There are clear non angiogenic white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy diseases, etc.
• Untreated cerebrovascular malformations or intracranial aneurysms (d \> 3mm).
• Active gastrointestinal bleeding.
• Coagulation dysfunction or history of systemic bleeding.
• Hemorrhagic tendency (including but not limited to)：PLT\<100×109/L; heparin treatment within 48h; APTT ≥ 35s; current use of warfarin, INR \> 1.7; current use of novel oral anticoagulants; current use of direct thrombin or factor Xa inhibitor.
• Severe hepatic or renal or heat insufficiency before randomization (severe hepatic insufficiency refers to ALT or AST \> 2 times the upper limit of normal; severe renal insufficiency refers to serum creatinine\> 1.5 times the upper limit of normal or eGFR\<40 ml/min/1.73m2; severe heat insufficiency refers to NYHA stage 3 and 4).
• History of intracranial or intramedullary surgery within three months of randomization.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Tasly Pharmaceutical Group Co., Ltd: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100070, China

Location

Related Publications (1)

• Zhou M, Gong Y, Han S, Wang M, Gu W, Chen HS, Zheng W, Feng K, Wang D, Li H, Zheng Z, Pan Y, Chen W, Wang Y. CerebrAlcare Pills on CereBral Small VesseL DiseasE (CABLE) trial: rationale and design. Stroke Vasc Neurol. 2025 Sep 2:svn-2024-003756. doi: 10.1136/svn-2024-003756. Online ahead of print.

  PMID: 40897453 DERIVED

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yilong Wang, PhD，MD

  Beijing Tiantan Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Beijing Tiantan Hospital

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: October 13, 2022
• Study Start: June 5, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)