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Diagnostic Test for Alzheimer's Disease (DTAD Trial)

Q: Is this trial available to geriatric patients?

In accordance with the rules of this medical experiment, participants must be at least 60 years old but no more than 90.

Q: Are there any open spots available for participation in this research?

Affirmative. The clinicaltrials.gov website indicates that the trial, which was initially posted on February 4th 2020 and recently updated on January 27th 2022, is actively enrolling participants; with a total goal of 240 patients across 3 different sites.

Q: What criteria must an individual meet to be admitted into this research project?

This medical research is seeking 240 participants between the ages of 60 and 90 who have been diagnosed with <a href="https://www.withpower.com/clinical-trials/alzheimer&#x27;s-disease">Alzheimer's disease</a>. Eligibility criteria includes: a confirmed diagnosis, current status as an ADC study subject, BMI in the range of 20-35, positive AD pathology present in their central nervous system (CNS), and completion of proxy signature if applicable.

Q: What are the main objectives of this clinical experiment?

This <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> trial will measure the response of Plasma Aβ and t-tau levels at 5, 30, 60, and 180 minutes post-challenge. Secondary metrics being examined include a decrease in WMS-III Logical Memory (ranging from 0 to 25), an increase in Trailmaking Test Part B (0 - 300 seconds) , and a reduction in CLOX paradigm results (ranged between 0 to 3).

Q: Have there been previous examinations utilizing Pramlintide as an experimental tool?

Currently, only 1 clinical trial is underway for Pramlintide challenge test and none of them are in the last phase. The trials are predominantly based out of Jamaica Plain, <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a> but there are 3 other sites conducting research on this procedure.

Q: How many people are enrolled in this experiment?

Affirmative. Clinicaltrials.gov records show that this clinical trial, which was initially posted on February 4th 2020, is currently recruiting participants. Approximately 240 patients must be enrolled from 3 different medical centres.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 and 24 months post challenge

Awards & highlights

DTAD Trial 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.Check my eligibility

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.See study design

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.

DTAD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 and 24 months post challenge

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Plasma Aβ and t-tau changes

Plasma inflammatory changes

Plasma metabolic changes in blood

Secondary outcome measures

Change in CDR

Change in CLOX paradigm

Change in Controlled Oral Word Association Test

+4 more

Side effects data

From 2022 Phase 4 trial • 22 Patients • NCT01841359

18%

Hypoglycemia

14%

Nausea

Ethanol abuse / intoxication

Trembling

Diarrhea (with urgency and incontinence)

Symptoms of a urinary tract infection (UTI) (CVA tenderness w/ dysuria)

Increase in baseline anxiety.

Auditory hallucinations

Cold feeling behind eyes.

Nightmares

Hyperglycemia

Elevated liver enzymes

Altered taste (during treatment with study drug)

Cholecystitis (prior to treatment with study drug)

Sinus infection (Visit 4, following treatment with study drug)

Weight loss (during study drug treatment)

Dehydration (r/t diarrhea)

Diarrhea (assoc. with dehydration requiring hospitalization)

100%

80%

60%

40%

20%

Study treatment Arm

Pramlintide (Symlin)

DTAD 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor

454 Previous Clinical Trials

9,941,330 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,645 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial available to geriatric patients?

"In accordance with the rules of this medical experiment, participants must be at least 60 years old but no more than 90."

Answered by AI

Are there any open spots available for participation in this research?

"Affirmative. The clinicaltrials.gov website indicates that the trial, which was initially posted on February 4th 2020 and recently updated on January 27th 2022, is actively enrolling participants; with a total goal of 240 patients across 3 different sites."

Answered by AI

What criteria must an individual meet to be admitted into this research project?

"This medical research is seeking 240 participants between the ages of 60 and 90 who have been diagnosed with Alzheimer's disease. Eligibility criteria includes: a confirmed diagnosis, current status as an ADC study subject, BMI in the range of 20-35, positive AD pathology present in their central nervous system (CNS), and completion of proxy signature if applicable."

Answered by AI

What are the main objectives of this clinical experiment?

"This experimental trial will measure the response of Plasma Aβ and t-tau levels at 5, 30, 60, and 180 minutes post-challenge. Secondary metrics being examined include a decrease in WMS-III Logical Memory (ranging from 0 to 25), an increase in Trailmaking Test Part B (0 - 300 seconds) , and a reduction in CLOX paradigm results (ranged between 0 to 3)."

Answered by AI

Have there been previous examinations utilizing Pramlintide as an experimental tool?

"Currently, only 1 clinical trial is underway for Pramlintide challenge test and none of them are in the last phase. The trials are predominantly based out of Jamaica Plain, Massachusetts but there are 3 other sites conducting research on this procedure."

Answered by AI

How many people are enrolled in this experiment?

"Affirmative. Clinicaltrials.gov records show that this clinical trial, which was initially posted on February 4th 2020, is currently recruiting participants. Approximately 240 patients must be enrolled from 3 different medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Multi-Center Development of a Novel Diagnostic Test for Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03560960.

All > Alzheimer Disease > Alzheimers Disease