DelfaGLP-1 Atlas

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GAPP-SVD

RecruitingPhase 2

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

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

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

110

estimated

Study population

Alzheimer's / cognition

Key I/E criterion

—

Primary endpoint

•Brain Peak Width of Skeletonized Mean Diffusivity

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05356104
Org study IDGAPP-SVD

Timeline

Milestones

Study first posted2022-05-02actual
Study start2022-05-25actual
Last update posted2026-02-24actual
Primary completion2026-05estimated (month precision)
Study completion2026-12estimated (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Alzheimer's / cognition

Eligibility

Who can enroll

Minimum age55 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Chinese ethnicity;

2. Age 55 to 80 years old;

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

4. Modified Functional Ambulation Classification 5 or above;

5. Montreal Cognitive Assessment (MoCA) score < 25;

6. Both diabetic and non-diabetic patient are eligible;

7. Patient who understands the purpose and requirements of the study, and able to provide an informed consent;

Exclusion criteria

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

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

3. 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;

4. BMI <18.5kg/m2;

5. 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;

6. Medical condition that would not allow the patient to adhere to the protocol or complete the study.;

7. Patient with established neurodegenerative disorders (e.g. Parkinson's Disease, Alzheimer's Disease, etc.);

8. Pregnancy.

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
7
Other (unclassified)
3
Patient-reported / QoL
2
Cardiovascular outcomes
1
Cardiometabolic biomarkers
1

Cardiovascular outcomes

1 endpoint
Secondary/protocol endpoint

Number of recurrent stroke

Time frame:Baseline and week 78

Stroke (any)

event count, event

SNOMED 230690007

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change of Pulsatility Index

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

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Change The Chinese Geriatric Depression Scale 30

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

change from baseline, improvement

Secondary/protocol endpoint

Change of Pittsburgh sleep quality index

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

change from baseline, improvement

Other clinical outcomes

7 endpoints
Secondary/protocol endpoint

Change of Hong Kong MOntreal Cognitive Assessment

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

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change of Hong Kong List Learning Test

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

change from baseline, improvement

Secondary/protocol endpoint

Change of Neuropsychiatric Inventory

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

change from baseline, improvement

Secondary/protocol endpoint

Change of disability assessment for dementia

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

change from baseline, improvement

Secondary/protocol endpoint

Change of Gait

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

change from baseline, improvement

Secondary/protocol endpoint

Change of balance

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

change from baseline, improvement

Secondary/protocol endpoint

Change of Breath Holding Index

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

change from baseline, improvement

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Change of Brain Peak Width of Skeletonized Mean Diffusivity

Time frame:Baseline and week 78

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change of DNA methylation

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

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change of neurovascular inflammation

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

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.