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DTAD

Active not recruitingPhase EARLY_1

Multi-Center Development of a Novel Diagnostic Test for Alzheimer's Disease

Lead sponsor

Boston University

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Alzheimer's / cognition, Healthy volunteers

Key I/E criterion

•BMI 20-35

Primary endpoints

•Plasma Aβ 1-40 levels•Plasma Aβ1-42 levels•Plasma Aβ and t-tau changes

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 IDNCT03560960

Org study IDH-37432

Secondary ID1R01AG059424-01

Timeline

Milestones

Study first posted2018-06-19actual

Study start2020-02-04actual

Last update posted2026-05-28actual

Primary completion2026-11estimated (month precision)

Study completion2026-11estimated (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Alzheimer's / cognitionHealthy volunteers

Eligibility

Who can enroll

Minimum age60 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Current research subjects at the BU , Memory Center VA Boston Healthcare, or Indiana University Alzheimer Disease Center

•A consensus diagnosis of probable Alzheimer's Disease (AD), amnestic mild cognitive impairment (MCI), or control

•BMI of 20-35

•Probable AD subjects must be confirmed for positive AD pathology in the central nervous center (CNS0

•Probable AD subjects must have a designated research proxy signed before they became demented.

Exclusion criteria

•Diabetes mellitus

•Gastroparesis

•Use of insulin, pramlintide, other injectable anti-hyperglycemic agents, such as glucagon like peptide-1 (GLP-1), or oral anti-diabetic products

•Unexplained hypoglycemia (glucose ≤ 60 mg/dL) or hyperglycemia (glucose ≥ 126 mg/dL) pre-injection

•History of stroke

•Seizures or use of anti-seizure medications

•History of brain injury and loss of consciousness

•Diagnosed cerebral amyloid angiopathy (CAA)

•Infection within 1 month

Endpoints (3)

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.

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Plasma Aβ 1-40 levels

Time frame:baseline, 5, 30, 60, and 180 min after challenge test

concentration, descriptive

Primary/protocol endpoint/low confidence

Plasma Aβ1-42 levels

Time frame:baseline, 5, 30, 60, and 180 min after challenge test

concentration, descriptive

Primary/protocol endpoint/low confidence

Plasma Aβ and t-tau changes

Time frame:baseline, 5, 30, 60, and 180 min after challenge test

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.