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Tau PET Outcomes with Anti-amyloid Immunotherapies

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Mayo Clinic

Status and phase

Invitation-only
Phase 2

Conditions

Alzheimer Disease
Dementia, Mild
Cognitive Impairment, Mild

Treatments

Drug: 18F-AV-1451

Study type

Interventional

Funder types

Other

Identifiers

NCT06723015
24-004371

Details and patient eligibility

About

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.

Enrollment

135 estimated patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

135 participants in 2 patient groups

Control Group
No Intervention group
Description:
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).
Treatment Group
Experimental group
Description:
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.
Treatment:
Drug: 18F-AV-1451

Trial contacts and locations

1

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Central trial contact

Petrice Cogswell, M.D., Ph.D.; Casey McAdam

Data sourced from clinicaltrials.gov

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