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Recruiting NCT05356104

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

Phase II Interventional Cerebral Small Vessel Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GLP-1 receptor agonist.
Who it may be relevant to
Registry conditions: Cerebral Small Vessel Disease. Basic parameters: 55 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China, Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

In this single-center, open-label (assessor blinded), randomized controlled study, 110 patients with cSVD of Age-Related White Matter Changes Scale of 2 or 3 will be randomized into "treatment arm" with GLP-1R agonist and standard medical therapy, and "control" arm with standard medical therapy alone in a 1:1 ratio. In this 78 weeks pilot study, investigators shall evaluate the tolerability and safety profile of GLP-1R agonist in SVD patients, together with changes in clinical, imaging and sonographic parameters.

Clinical and biochemical measures will be assessed at baseline, 12 weeks, 26 weeks and 52 weeks. Transcranial Doppler Ultrasound (TCD) will be performed at baseline, 12 weeks, 26 weeks, 52 weeks and 78 weeks. MRI will be performed at baseline and 78 weeks

Interventions

  • Drug GLP-1 receptor agonist
    2mg once weekly via subcutaneous injection

Primary outcome measures

  • Change of Brain Peak Width of Skeletonized Mean Diffusivity [Time frame: Baseline and week 78]
Secondary outcome measures (12)
  • Number of recurrent stroke [Time frame: Baseline and week 78]
  • Change of Hong Kong MOntreal Cognitive Assessment [Time frame: Baseline, week 12, week 26, week 52 and week 78]
  • Change The Chinese Geriatric Depression Scale 30 [Time frame: Baseline, week 12, week 26, week 52 and week 78]
  • Change of Pittsburgh sleep quality index [Time frame: Baseline, week 12, week 26, week 52 and week 78]
  • Change of Hong Kong List Learning Test [Time frame: Baseline, week 12, week 26, week 52 and week 78]
  • Change of Neuropsychiatric Inventory [Time frame: Baseline, week 12, week 26, week 52 and week 78]
  • Change of disability assessment for dementia [Time frame: Baseline, week 12, week 26, week 52 and week 78]
  • Change of Gait [Time frame: Baseline, week 12, week 26, week 52 and week 78]
  • Change of balance [Time frame: Baseline, week 12, week 26, week 52 and week 78]
  • Change of Pulsatility Index [Time frame: Baseline, week 12, week 26, week 52 and week 78]
  • Change of Breath Holding Index [Time frame: Baseline, week 12, week 26, week 52 and week 78]
  • Change of DNA methylation [Time frame: Baseline, week 12, week 26, week 52 and week 78]

Eligibility criteria

Inclusion criteria

  • 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;
  • Montreal Cognitive Assessment (MoCA) score < 25;
  • Both diabetic and non-diabetic patient are eligible;
  • Patient who understands the purpose and requirements of the study, and able to provide an informed consent;

Exclusion criteria

  • 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;
  • Contraindication to proposed imaging, e.g. chronic kidney disease (KDNIGO) stage 4 or above, acute kidney injury, hypersensitivity to gadolinium-based contrast, non-MRI conditional implants or prosthesis;
  • Medical condition that would not allow the patient to adhere to the protocol or complete the study.;
  • Patient with established neurodegenerative disorders (e.g. Parkinson's Disease, Alzheimer's Disease, etc.);
  • Pregnancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • First Affiliated Hospital of Wenzhou Medical University — Wenzhou
Hong Kong · 1 center
  • Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT05356104 · GAPP-SVD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗