NCT01713816

Brief Summary

Antioxidants are important for having a good memory and for smart thinking when people get old, and that is important for everyone's quality of life. This research will find out if normal aging and Alzheimer's disease use up brain antioxidants. It will develop a new imaging tool that can help doctors to stop cognitive decline.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2018

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

4 years

First QC Date

October 22, 2012

Last Update Submit

May 1, 2019

Conditions

Keywords

GlutathioneAscorbateAlzheimer's diseaseAgingMagnetic Resonance Spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Antioxidant in Alzheimers

    Occipital cortex and posterior cingulate ascorbate and glutathione concentration in young and elder patients as well as in patients with AD

    1 year

Study Arms (1)

Elderly control

Healthy elderly subjects age and gender matched to the AD cohort, predominantly male

Eligibility Criteria

Age65 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

All data have been accrued for the healthy aging aim, which included healthy people age 18-22 and age 70-89. To study the second aim, 23 patients with AD will be recruited from the Minneapolis, MN VA medical center. 23 age - and gender- matched controls will be recruited to study neurodegenerative disease associated demand on the antioxidant system. We do NOT currently have the resources to screen candidates with AD who are not current patients at the VA medical center in Minneapolis.

You may qualify if:

  • Age and gender match to AD patients: age range 65-89:
  • note that we anticipate that our patients will be predominantly male, so we are NOT likely to enroll females for this portion of the study

You may not qualify if:

  • Claustrophobia Implanted metal devices Pregnancy \> RDA dietary supplements
  • ≥ 5 F+V per day Smoking Depression Poor health or systemic illness Medial history of or evidence for cognitive problems Unstable medication usage Neurological problems Psychiatric disorder Substance abuse Usage of investigational drugs Inability to complete cognitive tests written in and calibrated for English speakers Inadequate vision or hearing to accommodate participation MMSE (dementia) score ≤ 26

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Melissa Terpstra, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 25, 2012

Study Start

June 1, 2013

Primary Completion

June 1, 2017

Study Completion

July 24, 2018

Last Updated

May 3, 2019

Record last verified: 2019-05

Locations