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CompletedNCT03291340DISCoVeRUpdated Dec 5, 2024

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

An observational study in Cognitive Impairment, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
27
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cognitive Impairment
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  1. Males and females ≥ 60 years of age.
  2. Fluent in English.
  3. 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.
  4. Has consented to participate in the ADCC high-resolution MRI sub-study.
  5. NACC longitudinal visit must be within 6 months of the TCD study and brain MRI study.
  6. Women: post-menopausal or surgically sterile.
  7. Willing and able to complete all required study procedures.
  8. Completed 6 grades of education.
  9. Geriatric Depression scale less than 6 (assessed within 6 months at the NACC longitudinal visit).

Exclusion criteria

Exclusion Criteria:

  1. Prior clinically symptomatic ischemic or hemorrhagic stroke.
  2. Inability to tolerate or contraindication to TCD study in the opinion of an investigator or treating physician.
  3. Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
27 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

05

What researchers measure

Primary outcomes

  1. Presence of right-to-left shunt on TCD

    Time frame: Baseline

  2. Presence of cerebrovascular reactivity on TCD

    Time frame: Baseline

Secondary outcomes

  1. Volume of ischemic injury

    Time frame: Baseline

  2. Location of ischemic injury

    Time frame: Baseline

  3. Presence of cognitive impairment

    Time frame: Baseline

  4. Type of cognitive impairment

    Time frame: Baseline

06

Study locations

1 site
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03291340
Lead sponsor
University of Pennsylvania
Responsible party
Steven Messe (Associate Professor of Neurology, University of Pennsylvania) — Principal investigator
First posted
Sep 25, 2017
Start date
Oct 26, 2017
Primary completion
Oct 1, 2023
Completion
Oct 1, 2023
Last update
Dec 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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