SLD3: Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia

Sponsor

Mayo Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT02736695

Collaborator

(none)

200

Enrollment

Location

Arm

167

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Progressive Aphasia	Drug: F-18 AV 1451	N/A

Detailed Description

Primary progressive aphasia (PPA) is an umbrella term that encompasses a group of neurodegenerative syndromes characterized by varying combinations of progressive speech and language problems. Three clinical variants of PPA have been described and are well recognized: the agrammatic variant characterized by grammatical errors in speech and writing and typically associated with phonetic errors in speech; the semantic variant characterized by poor naming from loss of knowledge about the meaning of words; and the logopenic variant characterized by word retrieval problems and poor sentence repetition from impairment of working memory and phonemic errors. Pathological studies of PPA patients that died with postmortem examination of their brains have demonstrated that PPA is associated with a number of different abnormal cellular proteins that do not have perfect associations with the three PPA variants. One such protein is the microtubule associated protein, tau, which is the most common abnormal protein found in the brains of patients with PPA. Tau is an important protein that has been linked to the neurodegenerative process in many diseases. No neuroimaging studies have investigated tau deposition in PPA and hence the binding characteristics of AV-1451 (the Tau binding drug used in this study) in PPA are unknown. Understanding the binding characteristics of AV-1451 is crucial to help determine whether it can serve as a biomarker for tau deposition in the brains of patients with PPA.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia

Actual Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2030

Anticipated Study Completion Date :

Jun 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tau PET Scan, F-18 AV 1451 All subjects will receive a Tau PET scan.	Drug: F-18 AV 1451 Tau binding agent

Arm

Intervention/Treatment

Experimental: Tau PET Scan, F-18 AV 1451

All subjects will receive a Tau PET scan.

Drug: F-18 AV 1451

Tau binding agent

Outcome Measures

Primary Outcome Measures

The investigators will be looking at the amount of Tau protein in the brain of patients with PPA. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 or language
Must fulfill diagnostic criteria for Primary Progressive Aphasia

Exclusion Criteria:

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, behavioral variant frontotemporal dementia, progressive supranuclear palsy, and corticobasal syndrome will be excluded
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 behavioral variant frontotemporal dementia, progressive supranuclear palsy, or corticobasal syndrome respectively, will also 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).