Cognitive ImpairmentDISCoVeRNCT03291340
Determining the Impact of Shunting and CerebroVascular Reactivity on 7T MRI (DISCoVeR 7T MRI)
An observational study of Cognitive Impairment, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2017to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Cross-sectional Cohort Study of Right-to-left-shunt, Cerebrovascular Reactivity, Ischemic Infarct Burden on High Resolution MRI, and Cognitive Impairment in Elderly Subjects
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
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of right-to-left shunt on TCD
Measured: Baseline
Presence of cerebrovascular reactivity on TCD
Measured: Baseline
Secondary outcomes (4)
Volume of ischemic injury
Measured: Baseline
Location of ischemic injury
Measured: Baseline
Presence of cognitive impairment
Measured: Baseline
Type of cognitive impairment
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start26 Oct 2017
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Messe, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291340
- Sponsor's protocol ID
- 827852
- Acronym
- DISCoVeR
- Status last verified
- Dec 2024
- First submitted
- 15 Sep 2017
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Cross-sectional Cohort Study of Right-to-left-shunt, Cerebrovascular Reactivity, Ischemic Infarct Burden on High Resolution MRI, and Cognitive Impairment in Elderly Subjects
- ClinicalTrials.gov ID
- NCT03291340
- Acronym / sponsor ID
- DISCoVeR / 827852
- Conditions
- Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of right-to-left shunt on TCD
Time frame: Baseline
Presence of cerebrovascular reactivity on TCD
Time frame: Baseline
4 secondary outcomes
Volume of ischemic injury
Time frame: Baseline
Location of ischemic injury
Time frame: Baseline
Presence of cognitive impairment
Time frame: Baseline
Type of cognitive impairment
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of right-to-left shunt on TCD (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.