Trial Outcomes & Findings for Dementia With Lewy Bodies - Infinitome (NCT NCT04773041)
NCT ID: NCT04773041
Last Updated: 2024-11-01
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
91 participants
Primary outcome timeframe
Baseline
Results posted on
2024-11-01
Participant Flow
Participant milestones
| Measure |
Patients With DLB
Patients diagnosed with DLB enrolled from the HealthPartners Neuroscience Center.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
Patients With Alzheimer's Disease (AD)
Patients diagnosed with AD age and MMSE-matched, selected from the ADNI database.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
Patients With Normal Cognition (CN)
Patients diagnosed with normal cognition age matched, selected from the ADNI database.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
36
|
36
|
|
Overall Study
COMPLETED
|
18
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Patients With DLB
Patients diagnosed with DLB enrolled from the HealthPartners Neuroscience Center.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
Patients With Alzheimer's Disease (AD)
Patients diagnosed with AD age and MMSE-matched, selected from the ADNI database.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
Patients With Normal Cognition (CN)
Patients diagnosed with normal cognition age matched, selected from the ADNI database.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
|---|---|---|---|
|
Overall Study
Unable to data match
|
1
|
0
|
0
|
Baseline Characteristics
Dementia With Lewy Bodies - Infinitome
Baseline characteristics by cohort
| Measure |
Patients With DLB
n=18 Participants
Patients diagnosed with DLB enrolled from the HealthPartners Neuroscience Center.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
Patients With Alzheimer's Disease (AD)
n=36 Participants
Patients diagnosed with AD age and MMSE-matched, selected from the ADNI database.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
Patients With Normal Cognition (CN)
n=36 Participants
Patients diagnosed with normal cognition age-matched, selected from the ADNI database.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75 years
STANDARD_DEVIATION 6.6 • n=93 Participants
|
76 years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
74 years
STANDARD_DEVIATION 6.3 • n=27 Participants
|
75 years
STANDARD_DEVIATION 6.7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
85 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
79 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Education years
|
17 years
STANDARD_DEVIATION 4 • n=93 Participants
|
16 years
STANDARD_DEVIATION 3.6 • n=4 Participants
|
16 years
STANDARD_DEVIATION .99 • n=27 Participants
|
16 years
STANDARD_DEVIATION 4.1 • n=483 Participants
|
|
Mini-Mental State Examination (MMSE)
|
23 units on a scale
STANDARD_DEVIATION 2.2 • n=93 Participants
|
23 units on a scale
STANDARD_DEVIATION 2.6 • n=4 Participants
|
29 units on a scale
STANDARD_DEVIATION 2.6 • n=27 Participants
|
26 units on a scale
STANDARD_DEVIATION 2.5 • n=483 Participants
|
PRIMARY outcome
Timeframe: BaselineIdentify 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.
Outcome measures
| Measure |
Patients With DLB
n=18 Participants
Patients diagnosed with DLB enrolled from the HealthPartners Neuroscience Center.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
Patients With Alzheimer's Disease (AD)
n=36 Participants
Patients diagnosed with AD age and MMSE-matched, selected from the ADNI database.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
Patients With Normal Cognition (CN)
n=36 Participants
Patients diagnosed with normal cognition age-matched, selected from the ADNI database.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
|---|---|---|---|
|
Functional Connectivity Scores Between Pairs of Large Scale Brain Networks.
PH_all and FST_left
|
0.307 connectivity score
Standard Error 0.009
|
0.456 connectivity score
Standard Error 0.006
|
0.433 connectivity score
Standard Error 0.006
|
|
Functional Connectivity Scores Between Pairs of Large Scale Brain Networks.
SubNigComp_left and Caud_left
|
0.124 connectivity score
Standard Error 0.012
|
0.122 connectivity score
Standard Error 0.005
|
0.132 connectivity score
Standard Error 0.004
|
|
Functional Connectivity Scores Between Pairs of Large Scale Brain Networks.
SubNigComp_left and Caud_right
|
0.134 connectivity score
Standard Error 0.006
|
0.112 connectivity score
Standard Error 0.005
|
0.144 connectivity score
Standard Error 0.005
|
|
Functional Connectivity Scores Between Pairs of Large Scale Brain Networks.
SubNigComp_right and Caud_left
|
0.088 connectivity score
Standard Error 0.012
|
0.127 connectivity score
Standard Error 0.003
|
0.130 connectivity score
Standard Error 0.004
|
|
Functional Connectivity Scores Between Pairs of Large Scale Brain Networks.
SubNigComp_right and Caud_right
|
0.063 connectivity score
Standard Error 0.01
|
0.123 connectivity score
Standard Error 0.004
|
0.123 connectivity score
Standard Error 0.004
|
|
Functional Connectivity Scores Between Pairs of Large Scale Brain Networks.
PH_right and FST_left
|
0.164 connectivity score
Standard Error 0.008
|
0.374 connectivity score
Standard Error 0.006
|
0.344 connectivity score
Standard Error 0.006
|
|
Functional Connectivity Scores Between Pairs of Large Scale Brain Networks.
PH_right and FST_right
|
0.340 connectivity score
Standard Error 0.010
|
0.517 connectivity score
Standard Error 0.006
|
0.442 connectivity score
Standard Error 0.005
|
|
Functional Connectivity Scores Between Pairs of Large Scale Brain Networks.
PH_all and FST_right
|
0.359 connectivity score
Standard Error 0.011
|
0.530 connectivity score
Standard Error 0.005
|
0.493 connectivity score
Standard Error 0.005
|
SECONDARY outcome
Timeframe: BaselineClinical 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: 1. Caudate R/Substantia Nigra R and Clock Drawing Test 2. Caudate R/Substantia Nigra R and ADAS Number Cancellation 3. PH R/FST R and ADAS Construction Praxis 4. PH R/FST R and Clock Drawing Test
Outcome measures
| Measure |
Patients With DLB
n=18 Participants
Patients diagnosed with DLB enrolled from the HealthPartners Neuroscience Center.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
Patients With Alzheimer's Disease (AD)
n=36 Participants
Patients diagnosed with AD age and MMSE-matched, selected from the ADNI database.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
Patients With Normal Cognition (CN)
n=36 Participants
Patients diagnosed with normal cognition age-matched, selected from the ADNI database.
Infinitome: All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
|
|---|---|---|---|
|
Correlation of Clinical Measures and Functional Connectivity Scores
Caudate R/Substantia Nigra R and Clock Drawing Test
|
-0.50 correlation coefficient
|
-0.23 correlation coefficient
|
0.26 correlation coefficient
|
|
Correlation of Clinical Measures and Functional Connectivity Scores
Caudate R/Substantia Nigra R and ADAS Number Cancellation
|
-0.65 correlation coefficient
|
-0.01 correlation coefficient
|
-0.06 correlation coefficient
|
|
Correlation of Clinical Measures and Functional Connectivity Scores
PH R/FST R and ADAS Construction Praxis
|
-0.31 correlation coefficient
|
-0.05 correlation coefficient
|
-0.02 correlation coefficient
|
|
Correlation of Clinical Measures and Functional Connectivity Scores
PH R/FST R and Clock Drawing Test
|
-0.17 correlation coefficient
|
0.18 correlation coefficient
|
-0.03 correlation coefficient
|
Adverse Events
Patients With DLB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients With Alzheimer's Disease (AD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients With Normal Cognition (CN)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place