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Alzheimer's DiseasePhase 2NCT01202994

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

A Phase 2 study testing 18F-Flutemetamol in people with Alzheimer's Disease, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease
What is being tested?
18F-Flutemetamol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
May 2011to 14 Oct 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Utah Center for Alzheimer's Care, Imaging and Research

    Salt Lake City, Utah, 84108

Other trials in United States

About this study

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

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:

Read more
  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.

Read the 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.

Being tested
18F-Flutemetamol
Keywords
Alzheimer's disease, Mild cognitive impairment, PET, Practice effects
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-FlutemetamolDrug

    Also called 18F-39-F-6-OH-BTA1, [18FGE067], Flutametamol PET

    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.

Study groups in NCT01202994
Study groupRoleWhat they receive
FluteExperimentalFlutemetamol PET scan.
Receives: Drug: 18F-Flutemetamol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amyloid Deposition Obtained on a 18F-flutemetamol Brain Scan.

    Standardized Uptake Value Ratio on flutemetamol scan will be the imaging marker of Alzheimer's disease pathology.

    Measured: Imaging occurred during a single session with each subject.

Secondary outcomes (1)

  1. Change in Participant Z-score

    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.

    Measured: baseline, one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2010 (estimated)
  2. Study startMay 2011
  3. Primary completionMay 2016
  4. Study completion14 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01202994
Sponsor's protocol ID
43306
Status last verified
Jan 2018
First submitted
14 Sep 2010
Last updated
9 May 2023
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 18F-Flutemetamol in people with Alzheimer's Disease, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amyloid Deposition Obtained on a 18F-flutemetamol Brain Scan. (time frame: Imaging occurred during a single session with each subject.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01202994.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.

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