Tau PET Outcomes with Anti-amyloid Immunotherapies

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