Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
150

Summary

Conditions
  • Age Related Cognitive Decline
  • Alzheimer's Disease
  • Endothelial Dysfunction
  • Executive Dysfunction
  • Vascular Dementia
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 75 years and 125 years
Gender
Both males and females

Description

The main objective of this study is to determine if omega 3 PUFA can slow the accumulation of brain MRI derived white matter hyper-intensities (WMH) over 3 years in a population at risk for dementia. This trial is designed to collect preliminary data into the mechanism by which PUFA therapy operates...

The main objective of this study is to determine if omega 3 PUFA can slow the accumulation of brain MRI derived white matter hyper-intensities (WMH) over 3 years in a population at risk for dementia. This trial is designed to collect preliminary data into the mechanism by which PUFA therapy operates on the brain with special attention to the vascular components. The randomized, double-blind and controlled trial will rigorously test PUFA effects versus a placebo in non-demented elders over 3 years. This biomarker based trial will enroll 100 elders. Aim 1 will assess PUFA effects on neuroimaging parameter changes. Aim 2 will assess PUFA effects on blood-based biomarkers of endothelial health, and Aim 3 will collect preliminary data on PUFA effects on neuropsychological and functional parameters with special attention to the executive and speed of processing skills and gait speed.

Tracking Information

NCT #
NCT01953705
Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Gene Bowman, ND, MPH Oregon Health and Science University Principal Investigator: Lynne Shinto, ND, MPH Oregon Health and Science University