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

NCT01202994 | Completed Phase 2 Results DMC

• 1 other identifier: 43306
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; Mild cognitive impairment; PET; Practice effects

Outcome Measures

Primary Outcomes (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.

  Imaging occurred during a single session with each subject.

Secondary Outcomes (1)

• Change in Participant Z-score

  baseline, one week

Study Arms (1)

Flute

EXPERIMENTAL

Flutemetamol PET scan.

Drug: 18F-Flutemetamol

Interventions

18F-Flutemetamol DRUG

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.

Also known as: 18F-39-F-6-OH-BTA1, [18FGE067], Flutametamol PET

Flute

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

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

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

flutemetamol

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Dr. Kevin Duff
• Organization: University of Utah

kevin.duff@hsc.utah.edu

8015859983

Study Officials

• Kevin Duff, Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: May 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: October 14, 2020
• Last Updated: May 9, 2023
• Results First Posted: January 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)