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NCT04080544 · ClinicalTrials.gov registry record · Phase 2
Cognitive Decline and Alzheimer's Disease in the Dallas Lifespan Brain Study
A Phase 2 study of Alzheimer Disease and Cognitive Decline, sponsored by Neil M Rofsky, MD, MHA.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
- 1
- Study location
NCT04080544: Completed Phase 2 study of Alzheimer Disease and Cognitive Decline, sponsored by Neil M Rofsky, MD, MHA.
NCT04080544 is a Phase 2 study of Alzheimer Disease and Cognitive Decline that has completed, run by Neil M Rofsky, MD, MHA. The registered enrollment target is 125 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04080544, a Phase 2 study of Alzheimer Disease and Cognitive Decline, has completed, sponsored by Neil M Rofsky, MD, MHA.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators will conduct tau positron emission tomography (PET) scans on 125 adults using the radiopharmaceutical Flortaucipir F18 (\[18F\]AV-1451). This will allow the investigators to determine tau deposition across adults of different ages and assess the relationship of current tau burden to cognitive function and amyloid deposition collected over the previous 10-year interval.
Primary Outcome
Tau accumulation in the temporal lobe will be measured as the standardized uptake value ratio (SUVR) computed from each participant's \[18F\]AV-1451 PET scans averaged across six bilateral regions of interest (ROls) by normalizing regional counts to the whole cerebellum. The 6 ROls are: inferior temporal gyrus, middle temporal gyrus, superior temporal gyrus, entorhinal cortex, parahippocampal gyrus, and fusiform gyrus. Each participant's PET scan and the six bilateral ROIs will be coregistered t
Conditions Studied
Interventions
- PROCEDURE Positron Emission Tomography
- DRUG [18F]AV-1451
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2019-01-15 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 2 |
What the finished NCT04080544 record still lists
NCT04080544 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Positron Emission Tomography is the first listed.
NCT04080544 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04080544 about?
NCT04080544 is a clinical study titled "Cognitive Decline and Alzheimer's Disease in the Dallas Lifespan Brain Study". The investigators will conduct tau positron emission tomography (PET) scans on 125 adults using the radiopharmaceutical Flortaucipir F18 (\[18F\]AV-1451). This will allow the investigators to determine tau deposition across adults of different ages and assess the relationship of current tau burden t...
What is the current status of trial NCT04080544?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2019-01-15. Estimated completion is 2022-06-30.
What conditions does trial NCT04080544 study?
This clinical trial studies the following conditions: Alzheimer Disease, Cognitive Decline.
What interventions are being tested in trial NCT04080544?
The interventions under investigation include: Positron Emission Tomography (PROCEDURE), [18F]AV-1451 (DRUG).
Who is sponsoring clinical trial NCT04080544?
This trial is sponsored by Neil M Rofsky, MD, MHA, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04080544 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04080544's enrollment target sits among peer trials
125 137th of 306 higher than 169 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer 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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