Alzheimer DiseaseNCT03389698
Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD
An observational study of Alzheimer Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
Aging is the primary risk factor in aging-related dementia. An important initiating factor for the development and progression of cognitive impairment is disruption of the blood-brain barrier (BBB). BBB plays an important role in maintaining normal brain homeostasis and protecting neural tissues from toxins. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- GRASP Dynamic Contrast-Enhanced (DCE) MRI, 3T Brain Scan and Gadolinium-based Contrast Agent (GBCA) for MRI
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2018to 11 Jul 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy cognitively normal control subjects of both age cohorts will be recruited by the study coordinator from (i) a pool of established volunteer subjects at NYU Langone Health who previously participated in research and who have agreed to be contacted about future research, (ii) Health Insurance Portability and Accountability Act of 1996 (HIPAA)-compliant databases such as RedCap and DataCore, and (iii) individuals who have contacted NYU to express interest in participating in research as a healthy volunteer. Subjects with aMCI will be recruited by Dr. Wisniewski from an ongoing NIH-funded large grant at NYU Barlow Center.
Who may be able to join
- Subjects that have been diagnosed with aMCI ages 65-85
Who cannot join
- Pregnant, planning to get pregnant, or nursing.
- Claustrophobia
- Cardiac pacemaker
- Intracranial clips, metal implants, unremovable jewelries, metal in eyes.
- History or presence of any other major medical, neurologic or psychiatric conditions, such as Alzheimer's diseases, Parkinson's diseases, and stroke.
- Renal or liver disease as this may cause concerns related to Gad-based contrast agent
- Allergy to the contrast agent Gadolinium
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Developing Advanced Blood-Brain Barrier Permeability Imaging for Early Alzheimer's Disease
Aging is the primary risk factor in aging-related dementia. An important initiating factor for the development and progression of cognitive impairment is disruption of the blood-brain barrier (BBB). BBB plays an important role in maintaining normal brain homeostasis and protecting neural tissues from toxins. It is hypothesized that such changes known to be common in aging and can be an early process that precedes Alzheimer's Disease (AD). The microvascular changes related to subtle BBB disruption can be measured with permeability-surface area (PS) derived from GRASP DCE-MRI acquired less than 10 minutes, and the patterns of increased PS in normal and abnormal aging are different.
- Conditions
- Alzheimer Disease
- Being tested
- GRASP Dynamic Contrast-Enhanced (DCE) MRI, 3T Brain Scan, Gadolinium-based Contrast Agent (GBCA) for MRI
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRASP Dynamic Contrast-Enhanced (DCE) MRIDevice
Golden-angle Radial Sparse Parallel (GRASP) DCE MRI is an MRI sequence designed to improve spatial and temporal resolution while enabling retrospective reconstruction with flexible temporal resolution.
3T Brain ScanDevice
Up to 60 minutes, a portion of which uses the GRASP DCE-MRI sequence.
Gadolinium-based Contrast Agent (GBCA) for MRIDrug
Also called Gadavist/Gadobutrol
Gadavist/Gadobutrol is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Cognitively normal control participants aged 20 - 40 years. Participants will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 21 minutes of scan time. Receives: Device: GRASP Dynamic Contrast-Enhanced (DCE) MRI; Device: 3T Brain Scan; Drug: Gadolinium-based Contrast Agent (GBCA) for MRI | |
| Cohort B | Cognitively normal control participants aged 65 - 85 years. Participants will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 21 minutes of scan time. Receives: Device: GRASP Dynamic Contrast-Enhanced (DCE) MRI; Device: 3T Brain Scan; Drug: Gadolinium-based Contrast Agent (GBCA) for MRI | |
| Cohort C | Amnestic mild cognitive impairment (aMCI) patients aged 65 and older. Participants in Cohort C will be matched by age and gender to participants in Cohort B. Participants in Cohort C will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 9 minutes of scan time. Receives: Device: GRASP Dynamic Contrast-Enhanced (DCE) MRI; Device: 3T Brain Scan; Drug: Gadolinium-based Contrast Agent (GBCA) for MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Permeability Surface Area (PS) as Measured by GRASP DCE-MRI Sequence
PS is measured by quantifying the contrast agent flow through blood vessel walls per unit volume of brain while accounting for the blood flow rate in the vessel.
Measured: Up to 21 Minutes
Blood-Brain Barrier (BBB) Permeability as Measured by GRASP DCE-MRI Sequence
Golden-angle Radial Sparse Parallel (GRASP) dynamic contrast-enhanced (DCE) MRI sequence will be collected for the quantification of subtle BBB leakage throughout the brain.
Measured: Up to 21 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start18 Dec 2018
- Primary completion28 Jan 2022
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yulin Ge, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389698
- Sponsor's protocol ID
- 17-01336
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2017
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Advanced Blood-Brain Barrier Permeability Imaging for Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03389698
- Acronym / sponsor ID
- 17-01336
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 3 Jan 2018 (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.
Aging is the primary risk factor in aging-related dementia. An important initiating factor for the development and progression of cognitive impairment is disruption of the blood-brain barrier (BBB). BBB plays an important role in maintaining normal brain homeostasis and protecting neural tissues from toxins. It is hypothesized that such changes known to be common in aging and can be an early process that precedes Alzheimer's Disease (AD). The microvascular changes related to subtle BBB disruption can be measured with permeability-surface area (PS) derived from GRASP DCE-MRI acquired less than 10 minutes, and the patterns of increased PS in normal and abnormal aging are different.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Device: GRASP Dynamic Contrast-Enhanced (DCE) MRI, Device: 3T Brain Scan, Drug: Gadolinium-based Contrast Agent (GBCA) for MRICognitively normal control participants aged 20 - 40 years. Participants will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 21 minutes of scan time. |
| Cohort B | – | Device: GRASP Dynamic Contrast-Enhanced (DCE) MRI, Device: 3T Brain Scan, Drug: Gadolinium-based Contrast Agent (GBCA) for MRICognitively normal control participants aged 65 - 85 years. Participants will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 21 minutes of scan time. |
| Cohort C | – | Device: GRASP Dynamic Contrast-Enhanced (DCE) MRI, Device: 3T Brain Scan, Drug: Gadolinium-based Contrast Agent (GBCA) for MRIAmnestic mild cognitive impairment (aMCI) patients aged 65 and older. Participants in Cohort C will be matched by age and gender to participants in Cohort B. Participants in Cohort C will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 9 minutes of scan time. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy cognitively normal control subjects of both age cohorts will be recruited by the study coordinator from (i) a pool of established volunteer subjects at NYU Langone Health who previously participated in research and who have agreed to be contacted about future research, (ii) Health Insurance Portability and Accountability Act of 1996 (HIPAA)-compliant databases such as RedCap and DataCore, and (iii) individuals who have contacted NYU to express interest in participating in research as a healthy volunteer. Subjects with aMCI will be recruited by Dr. Wisniewski from an ongoing NIH-funded large grant at NYU Barlow Center.
Key inclusion criteria (1 listed)
- Subjects that have been diagnosed with aMCI ages 65-85
Key exclusion criteria (7 listed)
- Pregnant, planning to get pregnant, or nursing.
- Claustrophobia
- Cardiac pacemaker
- Intracranial clips, metal implants, unremovable jewelries, metal in eyes.
- History or presence of any other major medical, neurologic or psychiatric conditions, such as Alzheimer's diseases, Parkinson's diseases, and stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRASP Dynamic Contrast-Enhanced (DCE) MRIGolden-angle Radial Sparse Parallel (GRASP) DCE MRI is an MRI sequence designed to improve spatial and temporal resolution while enabling retrospective reconstruction with flexible temporal resolution. | Device | Cohort A, Cohort B, Cohort C |
| 3T Brain ScanUp to 60 minutes, a portion of which uses the GRASP DCE-MRI sequence. | Device | Cohort A, Cohort B, Cohort C |
| Gadolinium-based Contrast Agent (GBCA) for MRIAlso: Gadavist/GadobutrolGadavist/Gadobutrol is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system. | Drug | Cohort A, Cohort B, Cohort C |
Primary outcome
Permeability Surface Area (PS) as Measured by GRASP DCE-MRI Sequence
Time frame: Up to 21 Minutes
PS is measured by quantifying the contrast agent flow through blood vessel walls per unit volume of brain while accounting for the blood flow rate in the vessel.
Blood-Brain Barrier (BBB) Permeability as Measured by GRASP DCE-MRI Sequence
Time frame: Up to 21 Minutes
Golden-angle Radial Sparse Parallel (GRASP) dynamic contrast-enhanced (DCE) MRI sequence will be collected for the quantification of subtle BBB leakage throughout the brain.
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 30 Jan 2024.
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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.
Yulin Ge, MD principal investigator
NYU Langone Health
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 Alzheimer Disease, run by NYU Langone Health 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 1 inclusion and 7 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 30 Jan 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?
Permeability Surface Area (PS) as Measured by GRASP DCE-MRI Sequence (time frame: Up to 21 Minutes). 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 30 Jan 2024.