NCT04773041

Dementia With Lewy Bodies - Infinitome

Completed Results posted Last updated 1 November 2024

What this trial tests

trial testing Infinitome in Dementia With Lewy Bodies in 91 participants. Completed in 19 June 2023.

Timeline

27 April 2021

Primary endpoint
8 February 2023

19 June 2023

Quick facts

Lead sponsor	HealthPartners Institute
Status	Completed
Study type	OBSERVATIONAL
Enrollment	91
Start date	27 April 2021
Primary completion	8 February 2023
Estimated completion	19 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Infinitome

Conditions studied

• Dementia With Lewy Bodies — all drugs for Dementia With Lewy Bodies →

Sponsor

HealthPartners Institute

Who can join

Adults 40 to 90, any sex, with Dementia With Lewy Bodies. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Functional Connectivity Scores Between Pairs of Large Scale Brain Networks. Primary · 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.

PH_right and FST_left

Group	Value	95% CI
Patients With DLB	0.164	± 0.008
Patients With Alzheimer's Disease (AD)	0.374	± 0.006
Patients With Normal Cognition (CN)	0.344	± 0.006

PH_right and FST_right

Group	Value	95% CI
Patients With DLB	0.340	± 0.010
Patients With Alzheimer's Disease (AD)	0.517	± 0.006
Patients With Normal Cognition (CN)	0.442	± 0.005

PH_all and FST_left

Group	Value	95% CI
Patients With DLB	0.307	± 0.009
Patients With Alzheimer's Disease (AD)	0.456	± 0.006
Patients With Normal Cognition (CN)	0.433	± 0.006

PH_all and FST_right

Group	Value	95% CI
Patients With DLB	0.359	± 0.011
Patients With Alzheimer's Disease (AD)	0.530	± 0.005
Patients With Normal Cognition (CN)	0.493	± 0.005

SubNigComp_left and Caud_left

Group	Value	95% CI
Patients With DLB	0.124	± 0.012
Patients With Alzheimer's Disease (AD)	0.122	± 0.005
Patients With Normal Cognition (CN)	0.132	± 0.004

SubNigComp_left and Caud_right

Group	Value	95% CI
Patients With DLB	0.134	± 0.006
Patients With Alzheimer's Disease (AD)	0.112	± 0.005
Patients With Normal Cognition (CN)	0.144	± 0.005

SubNigComp_right and Caud_left

Group	Value	95% CI
Patients With DLB	0.088	± 0.012
Patients With Alzheimer's Disease (AD)	0.127	± 0.003
Patients With Normal Cognition (CN)	0.130	± 0.004

SubNigComp_right and Caud_right

Group	Value	95% CI
Patients With DLB	0.063	± 0.01
Patients With Alzheimer's Disease (AD)	0.123	± 0.004
Patients With Normal Cognition (CN)	0.123	± 0.004

Correlation of Clinical Measures and Functional Connectivity Scores Secondary · Baseline

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: 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

Caudate R/Substantia Nigra R and Clock Drawing Test

Group	Value	95% CI
Patients With DLB	-0.50
Patients With Alzheimer's Disease (AD)	-0.23
Patients With Normal Cognition (CN)	0.26

Caudate R/Substantia Nigra R and ADAS Number Cancellation

Group	Value	95% CI
Patients With DLB	-0.65
Patients With Alzheimer's Disease (AD)	-0.01
Patients With Normal Cognition (CN)	-0.06

PH R/FST R and ADAS Construction Praxis

Group	Value	95% CI
Patients With DLB	-0.31
Patients With Alzheimer's Disease (AD)	-0.05
Patients With Normal Cognition (CN)	-0.02

PH R/FST R and Clock Drawing Test

Group	Value	95% CI
Patients With DLB	-0.17
Patients With Alzheimer's Disease (AD)	0.18
Patients With Normal Cognition (CN)	-0.03

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Open label pilot of personalized, neuroimaging-guided theta burst stimulation in early-stage Alzheimer's disease.
   Kashyap B, Hanson LR, Gustafson SK, Barclay T, et al · · 2024 · cited 1× · PMID 39717698 · DOI 10.3389/fnins.2024.1492428