Dementia With Lewy BodiesNCT04773041
Dementia With Lewy Bodies - Infinitome
An observational study of Dementia With Lewy Bodies, run by HealthPartners Institute at 1 site in United States.
Trial summary
Dementia with Lewy bodies (DLB) is the second most common cause of dementia and is associated with parkinsonism, hallucinations, and cognitive fluctuations. Diagnosis is often either missed or delayed due to physician lack of familiarity with characteristic features, the inability of structural MRI to detect a… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Dementia With Lewy Bodies
- What is being tested?
- Infinitome
- Type of treatment
- Surgery or procedure
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 19 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HealthPartners Neurology Clinic in Saint Paul, MN undergoing care for DLB and subjects included in the ADNI database.
Who may be able to join
- Age 40-90 years
- Established DLB diagnosis
- Mini mental status exam (MMSE) >15
Who cannot join
- Other forms of dementia including, but not limited to Alzheimer's dementia, frontotemporal dementia, vascular dementia, normal pressure hydrocephalus (NPH), etc,
- Inability to tolerate brain function magnetic resonance imaging (fMRI)
- Risk of brain fMRI due to implants or metal.
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130
About this study
Official title: Connectomic Analysis in Dementia With Lewy Bodies: A Potential Diagnostic Imaging Biomarker
Dementia with Lewy bodies (DLB) is the second most common cause of dementia and is associated with parkinsonism, hallucinations, and cognitive fluctuations. Diagnosis is often either missed or delayed due to physician lack of familiarity with characteristic features, the inability of structural MRI to detect a pathological signature for this condition, and the lack of healthcare provider access to "indicative biomarkers" that are either unavailable at community clinics or costly due to lack of insurance coverage. The role of resting state function MRI (rs-fMRI) as a diagnostic biomarker has been underexplored in this disease. We propose using a novel cloud-based automated imaging software processing program that identifies abnormal brain networks or connectomes using resting state functional MRI (rs-fMRI) and data from the Human Connectome Project (HCP). Furthermore, the imaging protocol to capture this data is relatively short (15 minutes) and can be performed at most imaging centers, lending potential clinical applicability to this study. We intend to study dysfunctional large scale brain networks (LSBNs) in DLB by comparing rs-fMRI imaging data in this population with cognitively normal (CN) and mild Alzheimer's disease (AD) subjects from the Alzheimer's Disease Neuroimaging Initiative (ADNI)-2/3 database.
Read the detailed description
Omniscient, a for-profit, Sydney, Australia-based company, created the cloud-based software Infinitome, a program that utilizes data from the Human Connectome Project (HCP) together with machine learning to analyze diffusion tensor and resting-state fMRI imaging data from remote sites. The foundation for this imaging tool is based upon the HCP atlas, which has also informed prior publications from our group, including the Connectomic Atlas of the Human Cerebrum (Baker, Burks, Briggs, Conner, et al. 2018). The Infinitome program creates a subject specific version of the Human Connectome Project Multimodal Parcellation (HCP-MMP1) atlas using diffusion tractography. Analytics are performed on both diffusion tensor imaging and rs-fMRI. Outlier detection using a tangent space connectivity matrix is performed by comparing results with a subset of 300 normal HCP subject fMRI samples to determine the range of normal correlations for each regions of interest in a large scale brain network which include:
- Locus coeruleus vs. Nucleus basalis of Meynert
- Locus coeruelus vs. Intralaminar nucleus of the thalamus
- Nucleus basalis of Meynert vs. Intralaminar nuclei of the thalamus
- FST in the vs. Area PH in the lateral occipital lobe
- Substantia nigra vs. Caudate nucleus Clinical Measures will be correlated with functional connectivity scores to identify relationship between clinical symptoms and large scale brain networks in DLB
- Conditions
- Dementia With Lewy Bodies
- Being tested
- Infinitome
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfinitomeProcedure or surgery
All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
| Study group | Role | What they receive |
|---|---|---|
| Patients with DLB | Patients diagnosed with DLB enrolled from the HealthPartners Neuroscience Center. Receives: Procedure: Infinitome | |
| Patients with Alzheimer's disease (AD) | Patients diagnosed with AD age and sex-matched, selected from the ADNI database. Receives: Procedure: Infinitome | |
| Patients with normal cognition (CN) | Patients diagnosed with normal cognition age and sex-matched, selected from the ADNI database. Receives: Procedure: Infinitome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Connectivity Scores Between Pairs of Large Scale Brain Networks.
Identify functional connectivity scores between pairs of large scale brain networks as determined by connectomic analysis using rs-fMRI Infinitome software in order to compare functional connectivity scores between groups. Eight parcellation pairs were chosen as primary pairs of interest.
For each parcellation pair - Range [-1,1]. Higher positive score indicates greater connectivity.
Measured: Baseline
Secondary outcomes (1)
Correlation of Clinical Measures and Functional Connectivity Scores
Clinical Measures will be correlated with functional connectivity scores to identify relationship between clinical symptoms and large scale brain networks in DLB . Range [-1,1]. Higher score indicates greater connectivity.
Correlation of:
- Caudate R/Substantia Nigra R and Clock Drawing Test
- Caudate R/Substantia Nigra R and ADAS Number Cancellation
- PH R/FST R and ADAS Construction Praxis
- PH R/FST R and Clock Drawing Test
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start27 Apr 2021
- Primary completion8 Feb 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael H Rosenbloom, MD, Principal investigator, HealthPartners Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773041
- Sponsor's protocol ID
- A21-037
- Status last verified
- Oct 2023
- First submitted
- 22 Feb 2021
- Last updated
- 1 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connectomic Analysis in Dementia With Lewy Bodies: A Potential Diagnostic Imaging Biomarker
- ClinicalTrials.gov ID
- NCT04773041
- Acronym / sponsor ID
- A21-037
- Conditions
- Dementia With Lewy Bodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Posted 1 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dementia with Lewy bodies (DLB) is the second most common cause of dementia and is associated with parkinsonism, hallucinations, and cognitive fluctuations. Diagnosis is often either missed or delayed due to physician lack of familiarity with characteristic features, the inability of structural MRI to detect a pathological signature for this condition, and the lack of healthcare provider access to "indicative biomarkers" that are either unavailable at community clinics or costly due to lack of insurance coverage. The role of resting state function MRI (rs-fMRI) as a diagnostic biomarker has been underexplored in this disease. We propose using a novel cloud-based automated imaging software processing program that identifies abnormal brain networks or connectomes using resting state functional MRI (rs-fMRI) and data from the Human Connectome Project (HCP). Furthermore, the imaging protocol to capture this data is relatively short (15 minutes) and can be performed at most imaging centers, lending potential clinical applicability to this study. We intend to study dysfunctional large scale brain networks (LSBNs) in DLB by comparing rs-fMRI imaging data in this population with cognitively normal (CN) and mild Alzheimer's disease (AD) subjects from the Alzheimer's Disease Neuroimaging Initiative (ADNI)-2/3 database.
Detailed description
Omniscient, a for-profit, Sydney, Australia-based company, created the cloud-based software Infinitome, a program that utilizes data from the Human Connectome Project (HCP) together with machine learning to analyze diffusion tensor and resting-state fMRI imaging data from remote sites. The foundation for this imaging tool is based upon the HCP atlas, which has also informed prior publications from our group, including the Connectomic Atlas of the Human Cerebrum (Baker, Burks, Briggs, Conner, et al. 2018). The Infinitome program creates a subject specific version of the Human Connectome Project Multimodal Parcellation (HCP-MMP1) atlas using diffusion tractography. Analytics are performed on both diffusion tensor imaging and rs-fMRI. Outlier detection using a tangent space connectivity matrix is performed by comparing results with a subset of 300 normal HCP subject fMRI samples to determine the range of normal correlations for each regions of interest in a large scale brain network which include:
- Locus coeruleus vs. Nucleus basalis of Meynert
- Locus coeruelus vs. Intralaminar nucleus of the thalamus
- Nucleus basalis of Meynert vs. Intralaminar nuclei of the thalamus
- FST in the vs. Area PH in the lateral occipital lobe
- Substantia nigra vs. Caudate nucleus Clinical Measures will be correlated with functional connectivity scores to identify relationship between clinical symptoms and large scale brain networks in DLB
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with DLB | – | Procedure: InfinitomePatients diagnosed with DLB enrolled from the HealthPartners Neuroscience Center. |
| Patients with Alzheimer's disease (AD) | – | Procedure: InfinitomePatients diagnosed with AD age and sex-matched, selected from the ADNI database. |
| Patients with normal cognition (CN) | – | Procedure: InfinitomePatients diagnosed with normal cognition age and sex-matched, selected from the ADNI database. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HealthPartners Neurology Clinic in Saint Paul, MN undergoing care for DLB and subjects included in the ADNI database.
Key inclusion criteria (3 listed)
- Age 40-90 years
- Established DLB diagnosis
- Mini mental status exam (MMSE) >15
Key exclusion criteria (3 listed)
- Other forms of dementia including, but not limited to Alzheimer's dementia, frontotemporal dementia, vascular dementia, normal pressure hydrocephalus (NPH), etc,
- Inability to tolerate brain function magnetic resonance imaging (fMRI)
- Risk of brain fMRI due to implants or metal.
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 |
|---|---|---|
| InfinitomeAll patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program. | Procedure or surgery | Patients with Alzheimer's disease (AD), Patients with DLB, Patients with normal cognition (CN) |
Primary outcome
Functional Connectivity Scores Between Pairs of Large Scale Brain Networks.
Time frame: Baseline
Identify functional connectivity scores between pairs of large scale brain networks as determined by connectomic analysis using rs-fMRI Infinitome software in order to compare functional connectivity scores between groups. Eight parcellation pairs were chosen as primary pairs of interest. For each parcellation pair - Range [-1,1]. Higher positive score indicates greater connectivity.
1 secondary outcome
Correlation of Clinical Measures and Functional Connectivity Scores
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael H Rosenbloom, MD principal investigator
HealthPartners Neurology
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 Dementia With Lewy Bodies, run by HealthPartners Institute 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 3 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 1 Nov 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?
Yes. Results are posted in the registry (first posted 1 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Functional Connectivity Scores Between Pairs of Large Scale Brain Networks. (time frame: Baseline). 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 1 Nov 2024.