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NotablePrimary completion date: Jun 2025 to Nov 2026
Primary endpoints revised (3)
Eligibility criteria expanded, about 14 words
Secondary endpoints shortened, about 31 words
v24
MinorPrimary completion date: May 2025 to Jun 2025v23
MinorTrial status: Recruiting to Active, Not Recruiting
Enrollment target: estimated 240 to confirmed 57
Primary completion date: Mar 2025 to May 2025
Site details revised at 3 of 3 sites
v22
MinorPrimary completion date: Dec 2024 to Mar 2025v21
Show 19 earlier versionsHide 19 earlier versions
NotablePrimary completion date: Jul 2023 to Dec 2024
Study completion date: Jul 2023 to Nov 2026
v20
Minor2 versionsRe-verified since Jan 27, 2022, no change to tracked fieldsv18-v19
NotableTrial status: Suspended to Recruiting
Site details revised at 3 of 3 sites
v17
StoppedTrial status: Recruiting to SuspendedSponsor's reason: Currently suspended due to Covid-19 policies.
Site details revised at 3 of 3 sites
v16
MinorStart date changed from estimate of Feb 2020 to Feb 4, 2020v15
MinorStart date: Jan 2020 to Feb 2020v14
MinorStart date: Dec 2019 to Jan 2020v13
MinorStart date: Nov 2019 to Dec 2019v12
NotableTrial status: Not Yet Recruiting to Recruiting
Start date: Oct 2019 to Nov 2019
Site details revised at 3 of 3 sites
v11
MinorStart date: Sep 2019 to Oct 2019v10
MinorPrimary and study completion dates: Jun 2023 to Jul 2023
Start date: Aug 2019 to Sep 2019
v9
MinorStart date: Jul 2019 to Aug 2019v8
MinorStart date: Jun 2019 to Jul 2019v7
NotableStart date: Apr 2019 to Jun 2019v6
MinorCollaborators expanded, about 5 wordsv5
MinorStart date: Mar 2019 to Apr 2019v4
NotableStart date: Aug 6, 2018 to Mar 2019
Trial status: Enrolling by Invitation to Not Yet Recruiting
v3
NotableTrial status: Not Yet Recruiting to Enrolling by Invitation
Start date changed from estimate of Jul 2018 to Aug 6, 2018
Interventions: Pramlintide challenge test (Diagnostic Test) to Pramlintide challenge test (Drug)
Site contacts updated at 3 of 3 sites
v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In this multi-center study, the investigators plan to develop a simple blood-based test for early detection of Alzheimer's disease (AD). The test is based on a single injection of Pramlintide, an amylin analogue and FDA-approved drug currently used for treatment of diabetes. The investigative team has provided evidence in humans with full-blown AD and AD-relevant mouse models that a single injection of Pramlintide transiently renders the blood brain barrier (BBB) more permeable to Amyloidbeta (Aß) peptides, allowing their efflux from the brain compartment into the blood. This Aß efflux causes a corresponding transient elevation of blood levels of Aß, the magnitude of which the applicants believe is proportional to the brain amyloid load as determined by AV-45 PET. The measured difference in the level of plasma Aß taken just before and a short time after injection should reveal the magnitude of the transient increase in blood Aß levels.
Supportive preliminary data comes from later stage (full-blown) AD patients with more in-depth background studies in Tg2576 and 5X Familial Alzheimer's Disease (FAD) mouse models. If successful for use as an early AD biomarker (i.e., at the Mild Cognitive Impairment (MCI) stage), this could be a game-changer for both early AD diagnostics and clinical trials aimed at identifying and testing the efficacy of drugs useful for treatment of AD at early stages. If Pramlintide is effective in releasing mobile pools of Aß from the brain into the blood, this could also have some therapeutic potential, with the goal of reducing brain amyloid load.
Three groups of participants will be studied: 1) amnestic MCI with or without positive AD imaging pathology, 2) probable AD with positive imaging AD pathology, and 3) controls who have normal cognition and do not have memory complaints.