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GLP-1 Analogue in Preventing Progression of Small Vessel Disease (GAPP-SVD)

ConditionCerebral Small Vessel Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-80
SponsorChinese University of Hong Kong

About this trial

Cerebral small vessel disease (cSVD), a result of neurovascular cell dysfunction, is a major cause of stroke, dementia and mobility problems worldwide. Vascular risk factor control alone may not be sufficient to prevent the development of vascular cognitive impairment (VCI) in patients with cSVD according to previous clinical trials.

The presence of glucagon-like peptide-1 receptor (GLP-1R) in cerebral microglia may reveal a potential therapeutic target for prevention of cSVD progression and its disabling clinical outcomes. At the cellular and animal experimentation levels, GLP-1R agonist demonstrated reversal of some pathogenic processes in cSVD. However, its application to cSVD patients remains to be elucidated.

Investigator aims to investigate the safety and efficacy of GLP-1R agonist in patients with moderate-to-severe cSVD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Chinese ethnicity;

Age 55 to 80 years old;

Age-Related White Matter Change (ARWMC) Scale of 2 or early 3 in FLAIR MRI;

Modified Functional Ambulation Classification 5 or above;

Disqualifiers

Dementia or MoCA score lower than 2nd percentile of the age and education adjusted cutoff ;

Cerebral white matter changes unrelated to neurodegenerative, e.g. CADASIL, X-linked adrenoleukodystrophy, metabolic diseases, multiple sclerosis, etc.;

Contraindication to GLP-1R agonist, including thyroid carcinoma, pancreatic pathology, proliferative retinopathy, hypersensitivity to GLP-1R agonist and history of family history of multiple endocrine neoplasia;

BMI <18.5kg/m2;

Trial design

Design model

Parallel

Treatments tested in this trial

  • GLP-1 receptor agonist

    Drug

    2mg once weekly via subcutaneous injection

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: GLP-1 receptor agonistActive comparator 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change of Brain Peak Width of Skeletonized Mean Diffusivity

Peak Width of Skeletonized Mean Diffusivity is a robust, fully-automated and easy-to-implement marker for cerebral small vessel disease based on diffusion tensor imaging, white matter tract skeletonization and histogram analysis. It is a biomarker for brain MRI images.

Time frame
Baseline and week 78

Secondary outcomes

1

Number of recurrent stroke

Record of any recurrent stroke from medical note/system

Time frame
Baseline and week 78
2

Change of Hong Kong MOntreal Cognitive Assessment

Hong Kong MOntreal Cognitive Assessment (HK-MoCA) is a cognitive assessment tool. Score from 0 to 30 . The lower score reflect the worse the outcome.

Time frame
Baseline, week 12, week 26, week 52 and week 78
3

Change The Chinese Geriatric Depression Scale 30

The Chinese Geriatric Depression Scale is used to detect depressive mood. Score 0 to 30. The higher the score, the worse the outcome

Time frame
Baseline, week 12, week 26, week 52 and week 78
4

Change of Pittsburgh sleep quality index

Pittsburgh sleep quality index Chinese Version is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The questionnaire contains frequency questions related to sleep quality, each question scale from 0 to 3. The higher the score, the worse the outcome. There is no total score available for this assessment

Time frame
Baseline, week 12, week 26, week 52 and week 78

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Source ClinicalTrials.gov
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