Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia and Frontotemporal Dementia

NCT02736695 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 16-0017031R21NS094684-01
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to learn more about overall tau burden in the brain of patients with Primary Progressive Aphasia (PPA) and Frontotemporal Dementia.

Conditions

Primary Progressive Aphasia; Behavioral Variant of Frontotemporal Dementia; Frontotemporal Dementia, Behavioral Variant

Keywords

PPA; bvFTD; FTD

Outcome Measures

Primary Outcomes (1)

• Proportion of PPA Subjects That Showed Elevated Tau PET Binding Compared to Normal Controls

  The percentage of subjects who showed elevated tau PET binding in the following five categories: PPA Clinical Variant-logopenic (lvPPA), PPA Clinical Variant-semantic (svPPA), PPA Clinical Variant-agrammatic (agPPA), no clinical variant-healthy, and Unclassified Variant (PPA-U).

  1 week

Secondary Outcomes (1)

• Signature Patterns of Regional Tau PET Binding in Clinical PPA Variants

  1 Week

Other Outcomes (1)

• Variability in Patterns of Tau PET Binding

  1 Week

Study Arms (2)

Tau PET Scan, F-18 AV 1451

EXPERIMENTAL

All subjects will receive a Tau PET scan.

Drug: F-18 AV 1451

Normal Controls

NO INTERVENTION

Subjects from our NIH funded Mayo Clinic Study of Aging (U01 AG006786) who have completed the identical tau-PET protocol with AV-1451 and MRI and clinical protocols. These participants were not consented or enrolled in this study.

Interventions

F-18 AV 1451 DRUG

Tau binding agent

Tau PET Scan, F-18 AV 1451

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be over the age of 18
• Must speak English as your primary language
• Must have an informant who can provide independent evaluation of functioning
• Must present with a chief complaint of progressive impairment of speech/language or changes in behavior
• Must fulfill diagnostic criteria for Primary Progressive Aphasia or Frontotemporal Dementia

You may not qualify if:

• Any subject who is mute or whose speech is unintelligible will be excluded
• All subjects with concurrent illnesses that could account for speech and language deficits, such as traumatic brain injury, strokes or developmental syndromes, and subjects meeting criteria for another neurodegenerative disease, such as amnestic Alzheimer's type dementia, dementia with Lewy bodies, progressive supranuclear palsy, and corticobasal syndrome will be excluded
• All pregnant, post-partum and breast-feeding women will be excluded
• Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, etc.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma or intracranial neoplasm), or if they are medically unstable or are on medications that might affect brain structure or metabolism,(e.g. chemotherapy).
• Subjects who meet criteria for PPA and have mild behavioral changes, eye movement abnormalities or mild limb apraxia but who do not meet diagnostic criteria for, progressive supranuclear palsy or corticobasal syndrome respectively, will also be excluded.
• Subjects will be excluded from the study if they have any of the following genetic conditions which can increase the chance of cancer: Cowden disease, Lynch syndrome, hypogammaglobulinemia, Wiskott-Aldrich syndrome, and Down's syndrome.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Aphasia, Primary Progressive; Pick Disease of the Brain

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Results Point of Contact

• Title: Keith Josephs, M.D.
• Organization: Mayo Clinic

josephs.keith@mayo.edu

507-266-4106

Study Officials

• Keith A Josephs, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 13, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)