PiB PET Scanning in Speech and Language Based Dementias

NCT01623284 | Completed Phase 1 DMC

• 1 other identifier: 09-008772
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to determine whether there are clinical features that can be used as biomarkers to predict whether underlying Alzheimer's pathology is the cause of a speech and language based dementia. The primary hypothesis is that the proportion of patients who test positive for beta-amyloid deposition will vary across different speech and language based dementias.

Conditions

PPA; Primary Progressive Aphasia; Aphasia; Non-fluent Aphasia; Semantic Dementia; Apraxia of Speech; Primary Progressive Nonfluent Aphasia; Progressive Aphasia

Keywords

aphasia; apraxia of speech; language

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with different speech and language based dementia (SLD) subtypes who have a [N-methyl-11C]2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (PiB) positive positron emission tomography (PET) scan at presentation

  Study entry, approximately day 1 or day 2 of study

Secondary Outcomes (3)

• Percentage of patients who exhibit apraxia of speech as measured by the Apraxia of Speech Rating Scale at presentation

  Study entry, approximately day 1 or day 2 of study

• Temporoparietal hypometabolism as shown on [18-F]-fluoro-deoxy-glucose positron emission tomography (FDG-PET) scan at presentation

  Study entry, approximately day 1 or day 2 of study

• Grey matter loss as shown on magnetic resonance imaging (MRI) at presentation

  Study entry, approximately day 1 or day 2 of study

Study Arms (1)

PiB and FDG positron emission tomography (PET)

EXPERIMENTAL

All subjects will receive PiB and FDG PET diagnosis on approximately day 1 or day 2 of study to determine if they have beta-amyloid deposits in their brains.

Drug: C-11 PiB; Drug: F-18 FDG

Interventions

C-11 PiB DRUG

One time intravenous administration of 740 megabecquerel (MBq) of \[N-methyl-11C\]2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (PiB) (range 370 - 740 MBq).

Also known as: Pittsburgh Compound B

PiB and FDG positron emission tomography (PET)

F-18 FDG DRUG

One time intravenous administration of 629 megabecquerel (MBq) of \[18-F\]-fluoro-deoxy-glucose (FDG) (range 555 - 740 MBq).

Also known as: Fluorodeoxyglucose-18

PiB and FDG positron emission tomography (PET)

Eligibility Criteria

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

You may qualify if:

• Over the age of 18
• Has an informant/study partner who will be able to provide independent evaluation of functioning
• Speaks English as their primary language (including bilingual patients whose primary language is English)
• Fulfills diagnostic criteria for PPA (Primary Progressive Aphasia) or Progressive Apraxia of Speech
• Agrees to and is eligible to undergo MRI and PET scanning
• If woman of child bearing age, pt must agree to pregnancy test no more than 48 hours before the PET scans

You may not qualify if:

• Any concurrent illnesses that could account for speech and language deficits, such as:
• traumatic brain injury, strokes and developmental syndromes
• patients meeting criteria for another neurodegenerative disease (Alzheimer's Disease, Dementia with Lewy Bodies, behavioral variant frontotemporal dementia, progressive supranuclear palsy, corticobasal degeneration)
• Women who is pregnant or post-partum and breast-feeding
• Patients for which 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)
• Patient is mute (secondary to dysarthria only)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Aphasia, Primary Progressive; Aphasia; Aphasia, Broca; Frontotemporal Dementia; Apraxias; Primary Progressive Nonfluent Aphasia; Language

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Psychomotor Disorders; Communication; Behavior

Study Officials

• Keith A Josephs, M.D. MST, MSc

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant-Neurology

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 19, 2012
• Study Start: March 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

US (1)