Amyloid-related Imaging Abnormalities (Microbleeds) in Atypical AD

NCT01723553 | Completed Phase 1 DMC

• 1 other identifier: 12-007139
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to assess the demographic, clinical and imaging associations with the presence of microbleeds in atypical Alzheimer's disease. The primary hypothesis is that cognitive and functional performance will be poorer in atypical Alzheimer's subjects with microbleeds compared to those without microbleeds.

Conditions

Atypical Alzheimers Disease; Logopenic Variant of Primary Progressive Aphasia (LPA); Posterior Cortical Atrophy (PCA)

Keywords

aphasia; logopenic; PCA; LPA

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with and without microbleeds

  up to day 2 of study

Secondary Outcomes (2)

• Percentage of white matter hyperintensity burden on MRI and ratio of amyloid burden on PiB PET scan

  Study entry, approximately day 1 or day 2 of study

• Number of microbleeds per subject

  Study entry, approximately day 1 or day 2 of study

Study Arms (1)

PiB positron emission tomography (PET)

EXPERIMENTAL

All subjects will receive PET imaging with C-11 PiB on approximately day 1 or day 2 of study to determine if they have beta-amyloid deposits in their brains.

Drug: C-11 PiB

Interventions

C-11 PiB DRUG

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

Also known as: Pittsburgh Compound B, PiB

PiB 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 21
• will have an informant/study partner who will be able to provide independent evaluation of functioning
• must fulfill clinical diagnostic criteria for atypical AD, and hence should either have a chief complaint of difficulty with language and fulfill criteria for logopenic variant of primary progressive aphasia, or present with visuospatial/perceptual deficits and fulfill criteria for posterior cortical atrophy
• speaks English as their primary language (including bilingual patients whose primary language is English)
• agrees to and is eligible to undergo MRI and PET scanning
• if woman of child bearing age, must agree to pregnancy test no more than 48 hours before the PET scans

You may not qualify if:

• subjects with concurrent illnesses that could account for the presenting syndrome, such as traumatic brain injury, strokes or developmental syndromes
• subjects meeting criteria for another neurodegenerative disease, particularly typical Alzheimer's dementia
• women that are pregnant or post-partum and breast-feeding
• subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, e.t.c.), if there is severe claustrophobia, and if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma or intracranial neoplasm)
• subjects will also be excluded if they do not have an informant, do not consent to research or do not complete all components of the study (neurological exam, neuropsychometric tests, MRI, PiB PET)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Aphasia

Interventions

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

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Whitwell, PhD

  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: PI

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 8, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 21, 2015

Record last verified: 2015-12

Locations

US (1)