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NCT01202994 · ClinicalTrials.gov registry record · Phase 2
Practice Effects and Amyloid Imaging Using 18F-PIB or Flutemetamol PET and FDG-PET
A Phase 2 study of Alzheimers Disease, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT01202994: Completed Phase 2 study of Alzheimers Disease, sponsored by University of Utah.
NCT01202994 is a Phase 2 study of Alzheimers Disease that has completed, run by University of Utah. The registered enrollment target is 27 participants, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01202994, a Phase 2 study of Alzheimers Disease, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Standardized Uptake Value Ratio on flutemetamol scan will be the imaging marker of Alzheimer's disease pathology.
Conditions Studied
Interventions
- DRUG 18F-Flutemetamol
Study Locations (1)
Utah
- University of Utah Center for Alzheimer's Care, Imaging and Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-05 |
| Est. Completion | 2020-10-14 |
| Phase | Phase 2 |
What the finished NCT01202994 record still lists
NCT01202994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 1 intervention - of which 18F-Flutemetamol is the first listed.
NCT01202994 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT01202994 about?
NCT01202994 is a clinical study titled "Practice Effects and Amyloid Imaging Using 18F-PIB 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 neu...
What is the current status of trial NCT01202994?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2011-05. Estimated completion is 2020-10-14.
What conditions does trial NCT01202994 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT01202994?
The interventions under investigation include: 18F-Flutemetamol (DRUG).
Who is sponsoring clinical trial NCT01202994?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01202994 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01202994's enrollment target sits among peer trials
27 121st of 147 higher than 27 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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