Determining the Impact of Shunting and CerebroVascular Reactivity on 7T MRI (DISCoVeR 7T MRI)

NCT03291340 | Completed

• 1 other identifier: 827852
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use transcanial doppler (TCD) ultrasound to look for possible risk factors for ischemic brain injury. We will perform contrast TCD with agitated saline contrast to identify and contrast right-to-left shunt (RLS) and breath holding to assess cerebrovascular reactivity (CVR) in the elderly.

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Presence of right-to-left shunt on TCD

  Baseline

• Presence of cerebrovascular reactivity on TCD

  Baseline

Secondary Outcomes (4)

• Volume of ischemic injury

  Baseline

• Location of ischemic injury

  Baseline

• Presence of cognitive impairment

  Baseline

• Type of cognitive impairment

  Baseline

Study Arms (2)

Cognitively normal elderly

TCD agitated saline right-to-left shunt study TCD cerebrovascular reactivity study

Cognitive impaired elderly

TCD agitated saline right-to-left shunt study TCD cerebrovascular reactivity study

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Only subjects that are enrolled in the NACC longitudinal cohort (Protocol 068200) will be eligible for this study. Subjects must also agree to participate in the ADCC high-resolution MRI sub-study to be eligible.

You may qualify if:

• Males and females ≥ 60 years of age.
• Fluent in English.
• Part of the NACC longitudinal cohort (Protocol #: 068200) of the PMC/ADCC with consensus conference designation of cognitively normal, Mild Cognitive Impairment, or probable/possible Alzheimer's disease.
• Has consented to participate in the ADCC high-resolution MRI sub-study.
• NACC longitudinal visit must be within 6 months of the TCD study and brain MRI study.
• Women: post-menopausal or surgically sterile.
• Willing and able to complete all required study procedures.
• Completed 6 grades of education.
• Geriatric Depression scale less than 6 (assessed within 6 months at the NACC longitudinal visit).

You may not qualify if:

• Prior clinically symptomatic ischemic or hemorrhagic stroke.
• Inability to tolerate or contraindication to TCD study in the opinion of an investigator or treating physician.
• Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 25, 2017
• Study Start: October 26, 2017
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)