Practice Effects and Amyloid Imaging Using 18F-PIB or Flutemetamol PET and FDG-PET

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01202994
First received: September 14, 2010
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

Alzheimer's disease (AD) is the most common cause of progressive cognitive decline in the United States. AD is characterized by severe impairments in learning, memory and other cognitive abilities that significantly interfere with daily functioning. The neuropathologic hallmarks of AD consist of neuritic plaques, neurofibrillary tangles, and selective neuronal cell loss. Amyloid plaques, which contain Abeta protein, are believed to play an integral role in the development of AD. Elevated levels of Abeta in the brain are also correlated with cognitive decline.

Alzheimer's (AD) develops insidiously, making it difficult to identify early, yet treatment is most effective when begun during the early stages of the disease. Thus, it has become important for researchers to identify markers of early AD. This project will examine the relationship between four potential markers that may indicate the early development of AD:

  1. Mild cognitive impairment (MCI)or normal cognition
  2. Practice effects
  3. Amyloid plaque binding on 18F-PIB PET
  4. Glucose hypometabolism on FDG PET

This project will recruit 25 subjects from an ongoing community-based study of memory and practice effects in cognitively normal, community-dwelling individuals who are age 65 and over (NIA #5K23AG028417-05). Each subject will undergo positron emission tomography (PET) with both 18F-Flutemetamol and FDG.

The overall objective of this companion project is to study the biodistribution and binding of 18F-Flutemetamol in these subjects using PET imaging, which will provide biological evidence to support the overall hypothesis that failure to benefit from practice on a learning paradigm is an early marker of AD.


Condition Intervention Phase
Alzheimer's Disease
Drug: 18F-Flutemetamol
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Practice Effects and Amyloid Imaging Using 18F-PIB (18F-39-F-6-OH-BTA1) Known as [18FGE067]) or Flutemetamol PET and FDG-PET

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Practice effects and FDG-PET perfusion will be correlated with amyloid deposition in 18F-PIB. [ Time Frame: All measures will be collected within six month. ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 18F-Flutemetamol

    All subjects will undergo a PET scan with 18F-PIB, within six months of also undergoing an FDG-PET scan (PET scans will occur on separate days).

    For the 18F-PIB PET scan: Approximately 185 MBq (5 mCi) of 18F-PIB will be injected intravenously and PET data collected for each subject.

    The FDG-PET scan will follow the same procedures as routine scans obtained in a clinical setting (approximately 370 MBq of 18F-FDG will be injected intravenously and PET data collected for each subject). FDG-PET data will be used to correlate metabolic changes and for anatomic co-registration of 18F-PIB images.

    Other Names:
    • 18F-39-F-6-OH-BTA1
    • [18FGE067]
    • Flutametamol PET
Detailed Description:

The overall objective of this companion study project is to study the biodistribution and binding of 18F-Flutemetamol using PET imaging in community-dwelling functionally intact elderly subjects. Understanding the biodistribution and binding of this radiopharmaceutical in normal patients with various levels of potential for cognitive decline will help determine its appropriate role as a disease biomarker and aid in the interpretation of images produced with this agent. Comparison with FDG-PET is essential to correlate metabolic changes and for anatomic co-registration of 18F-PIB images necessary for group analysis.

We will use 18F-Flutemetamol and FDG-PET to compare subjects with low and high practice effects with the following aims and hypotheses:

Specific Aim 1: Examine the relationship between practice effects and amyloid burden in a community sample.

Specific Aim 2: Determine whether FDG-PET or 18F-Flutemetamol better distinguish individuals with high and low practice effects.

Hypothesis 1: Practice effects will be negatively correlated with amyloid deposition, so that higher levels of practice effects (i.e., better repeat testing) will be associated with lower levels of brain amyloid deposition and lower levels of practice effects (i.e., poorer repeat testing) will be associated with greater levels of brain amyloid and these two groups are more clearly distinguishable with 18F-PIB than FDG-PET.

Hypothesis 2: Patients with increased amyloid deposition shown with 18F-PIB will have an FDG-PET scan with more pronounced temporal and parietal hypometabolism as noted on visual review of images and on statistical image analysis.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must be currently enrolled in an NIA-sponsored, community-based study of practice effects in non-demented adults age 65 and older living independently (NIA #5K23AG028417-05)

Exclusion Criteria:

  • History of neurological disease known to affect cognition (e.g., stroke, head injury with loss of consciousness of >30 minutes, seizure disorder, demyelinating disorder, mental retardation, etc.)
  • Dementia based on DSM-IV criteria
  • Current or past major psychiatric illness (e.g., schizophrenia, bipolar affective disorder)
  • 30-item Geriatric Depression Score >14
  • Evidence of stroke or mass lesion on CT or MRI scan
  • History of alcoholism or other substance abuse
  • Current use of cholinesterase inhibitors, other cognitive enhancers, antipsychotics, or anticonvulsant medications
  • History of radiation therapy to the brain
  • History of significant major medical illnesses, such as cancer or AIDS
  • Uncontrolled diabetes or blood glucose >180 mg/dl on the day of the FDG-PET scan
  • Currently pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202994

Locations
United States, Utah
University of Utah Center for Alzheimer's Care, Imaging and Research
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Kevin Duff, Ph.D. University of Utah
  More Information

Additional Information:
No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01202994     History of Changes
Other Study ID Numbers: 43306
Study First Received: September 14, 2010
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
Alzheimer's disease
Mild cognitive impairment
PET
Practice effects

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 21, 2014