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Clinical Trials/NCT03300726
NCT03300726
Completed
N/A

Cerebrospinal Fluid Markers of Synaptic Injury and Functional Connectivity in Alzheimer's Disease

Ohio State University1 site in 1 country35 target enrollmentFebruary 12, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer Disease, Late Onset
Sponsor
Ohio State University
Enrollment
35
Locations
1
Primary Endpoint
Correlations between CSF biomarker measurements and fMRI measures of functional connectivity at baseline
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to examine cross-sectional associations between CSF markers of synaptic injury (Ng and SNAP-25) and functional connectivity in default and semantic memory networks using 3T- fMRI in individuals with MCI (i.e. the earliest clinically detectable stage of cognitive impairment) due to AD or mild AD dementia (CDR 0.5-1; n=20) and cognitively normal controls (CDR 0; n=20).

Detailed Description

SPECIFIC AIMS: Aim 1: Investigate correlations between CSF biomarkers of synaptic injury (Ng and SNAP-25) and functional connectivity (FC) within the default mode network (DMN) using resting-state fMRI (adjusting for age, gender, apolipoprotein-E4 \[APOE4\] genotype, task performance, and regional brain atrophy) in MCI/AD and controls. Aim 2: Examine correlations between CSF biomarkers of synaptic injury and functional connectivity (FC) within the semantic memory network on task-activated fMRI using the Famous Name Discrimination Task (FNDT) (adjusting for age, gender, APOE4 genotype, task performance, and regional brain atrophy) in MCI/AD and controls.

Registry
clinicaltrials.gov
Start Date
February 12, 2018
End Date
September 22, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rawan Tarawneh

Assistant Professor of Neurology

Ohio State University

Eligibility Criteria

Inclusion Criteria

  • Participants included in the study should meet all 4 inclusion criteria:
  • 60 years of age or older
  • A clinical diagnosis of MCI, mild AD dementia, or normal cognition
  • No significant medical or surgical co-morbidities
  • No contraindications to LP or MRI.
  • Exclusion criteria: Participants with any of the following criteria will be excluded from the study:
  • Participants with MCI due to AD or mild AD dementia who have been treated with cholinesterase inhibitors or glutamate antagonists in the 3 months prior to study enrollment
  • Individuals with any past history of ischemic or traumatic brain injury
  • Individuals with imaging evidence of significant cerebrovascular disease or structural brain lesions (e.g. tumor, demyelinating disorders, infection, or congenital anomalies)
  • Active mood disorder

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Correlations between CSF biomarker measurements and fMRI measures of functional connectivity at baseline

Time Frame: Study duration is 3 years (36 months) for each participant, including 3 visits: one for cognitive evaluations, one for fMRI, and one for CSF collection.

Cross-sectional associations between CSF biomarker measurements and fMRI measures at baseline

Secondary Outcomes

  • Functional Connectivity measures on functional MRI (r)(fMRI will be performed for each participant once during the study (within 3 years of study enrollment).)
  • CSF levels of tau, p-tau181, Abeta42, Ng, and SNAP-25 (pg/ml)(CSF collection will be performed for each participant once during the study (within 3 years of study enrollment).)

Study Sites (1)

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