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Diagnostic Test for Alzheimer's Disease (DTAD Trial)

Phase < 1
Recruiting
Led By Wendy Qiu, MD PhD
Research Sponsored by Boston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
History of brain injury and loss of consciousness
Diabetes mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 and 24 months post challenge
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a possible blood test for early detection of Alzheimer's disease. The test is based on a single injection of Pramlintide, an FDA-approved drug currently used for treatment of diabetes.

Who is the study for?
This trial is for individuals with mild cognitive impairment or Alzheimer's, who are part of certain research centers and have a BMI between 20-35. Participants must not have diabetes, recent infections, history of stroke or brain injury, seizures, or use related medications. Those with probable AD need confirmed pathology and a designated proxy.
What is being tested?
Researchers are testing a blood-based diagnostic test for early Alzheimer's detection using Pramlintide. This drug may allow Amyloidbeta peptides to move from the brain into the blood after injection, potentially indicating brain amyloid levels.
What are the potential side effects?
While specific side effects aren't listed in this summary, Pramlintide generally can cause nausea, vomiting, decreased appetite and hypoglycemia (low blood sugar), especially since it is used in treating diabetes.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a brain injury with loss of consciousness.
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I have diabetes.
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I have been diagnosed with gastroparesis.
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I use insulin or other medications to manage my diabetes.
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I have had a stroke in the past.
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I have seizures or take medication for seizures.
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I have been diagnosed with cerebral amyloid angiopathy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 and 24 months post challenge
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 and 24 months post challenge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Plasma Aβ and t-tau changes
Plasma inflammatory changes
Plasma metabolic changes in blood
Secondary study objectives
Change in CDR
Change in CLOX paradigm
Change in Controlled Oral Word Association Test
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Probable ADExperimental Treatment1 Intervention
Participants with probable AD with positive imaging AD pathology will receive the pramlintide challenge test.
Group II: Amnestic MCIActive Control1 Intervention
Participants with amnestic MCI with or without positive AD imaging pathology will receive the pramlintide challenge test.
Group III: Control- Normal CognitionActive Control1 Intervention
Participants with normal cognition without any memory complaints will receive the pramlintide challenge test.

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor
472 Previous Clinical Trials
9,987,593 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,092 Total Patients Enrolled
Wendy Qiu, MD PhDPrincipal InvestigatorBoston Medical Center and BUSM

Media Library

Alzheimer's Disease Clinical Trial 2023: Pramlintide challenge test Highlights & Side Effects. Trial Name: NCT03560960 — Phase < 1
~12 spots leftby Mar 2025
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