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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01202994
Recruitment Status : Active, not recruiting
First Posted : September 16, 2010
Results First Posted : January 11, 2018
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):
Kevin Duff, University of Utah

Brief Summary:

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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: 18F-Flutemetamol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2011
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Flute
Flutemetamol PET scan.
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

Primary Outcome Measures :
  1. Amyloid Deposition Obtained on a 18F-flutemetamol Brain Scan. [ Time Frame: Imaging occurred during a single session with each subject. ]
    Standardized Uptake Value Ratio on flutemetamol scan will be the imaging marker of Alzheimer's disease pathology.

Secondary Outcome Measures :
  1. Change in Participant Z-score [ Time Frame: baseline, one week ]
    This z-scores is based on a test of visual learning and memory, which was administered to subjects twice across one week. The amount of change that individuals show across one week is the baseline measure assessed with this variable. We focused on the amount of change observed on the Delayed Recall trial of this test between baseline and one week (i.e., practice effect). The practice effect score on this test is represented as a z-score (M = 0, SD = 1), with higher scores indicating more improvement across one week, which is better result than lower scores.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01202994

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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
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Principal Investigator: Kevin Duff, Ph.D. University of Utah

Additional Information:
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Responsible Party: Kevin Duff, Phd, University of Utah Identifier: NCT01202994     History of Changes
Other Study ID Numbers: 43306
First Posted: September 16, 2010    Key Record Dates
Results First Posted: January 11, 2018
Last Update Posted: February 7, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Molecular Mechanisms of Pharmacological Action