Tau PET Outcomes With Anti-amyloid Immunotherapies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-04

Study Completion Date

2028-08-31

Brief Summary

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This is an imaging study of patients with mild Alzheimer's disease receiving amyloid-targeting therapy and under the care of neurologists at Mayo Clinic in Rochester, MN.

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Detailed Description

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Conditions

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Cognitive Impairment, Mild Dementia, Mild Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control Group

Untreated historical controls enrolled in Mayo Clinic Study of Aging (IRB 14-004401), Mayo Alzheimer's Disease Research Center (IRB 712-98), and Brain Amyloid Imaging with Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia (IRB 08-005553).

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment Group

Subjects with a diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease and amyloid positive, who are starting anti-amyloid immunotherapy.

Group Type EXPERIMENTAL

18F-AV-1451

Intervention Type DRUG

Subjects will receive two Tau PET (18F--AV-1451) brain scans with approximately 10 mCi (370 MBq) (+/- 10%mCi) of 18F-AV-1451. Images will be collected for a 20-minute acquisition between 80-100 minutes after injection.

Tau PET scans will occur at baseline and 12-18 months after completing anti-amyloid immunotherapy treatment..

Interventions

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18F-AV-1451

Subjects will receive two Tau PET (18F--AV-1451) brain scans with approximately 10 mCi (370 MBq) (+/- 10%mCi) of 18F-AV-1451. Images will be collected for a 20-minute acquisition between 80-100 minutes after injection.

Tau PET scans will occur at baseline and 12-18 months after completing anti-amyloid immunotherapy treatment..

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 50-90 years
* Male or female
* Mild cognitive impairment due to AD or mild AD
* Amyloid positive via CSF or PET
* Meets other eligibility criteria for anti-amyloid immunotherapy
* Subject or delegate provides informed consent

Exclusion Criteria

* Subjects unable to lie down without moving for 10 minutes.
* Women who are pregnant or cannot stop breast feeding for 24 hours.
* Claustrophobic patients unable to tolerate the scans (no sedation can be offered).

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No