Tau PET Outcomes With Anti-amyloid Immunotherapies

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	50 Years - 90 Years
Gender	All

More Inclusion & 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06723015
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Petrice Cogswell, M.D., Ph.D.
Principal Investigator Affiliation	Mayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cognitive Impairment, Mild, Dementia, Mild, Alzheimer Disease

Arms & Interventions

Arms

No Intervention: 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).

Experimental: 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.

Interventions

Drug: - 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..

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Rochester 5043473, Minnesota 5037779

Status

Address

Mayo Clinic

Rochester 5043473, Minnesota 5037779, 55905

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