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Completed

NCT Number: NCT03300726

Synaptic Injury and Functional Connectivity in Alzheimer's Disease

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).

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Key information

Conditions

Alzheimer Disease, Late Onset Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Active alcohol use
  • Active use of benzodiazepines, barbiturates, anticholinergic, or anti-epileptic medications

Treatment and study plan

CSF analysis

Diagnostic Test

CSF analysis for tau, p-tau181, Abeta42, and CSF levels of markers of synaptic injury

functional MRI

Radiation

Functional MRI during resting state and semantic memory task activation

Primary outcomes

  1. 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

  1. CSF levels of tau, p-tau181, Abeta42, Ng, and SNAP-25 (pg/ml)

    Time frame: CSF collection will be performed for each participant once during the study (within 3 years of study enrollment).

    Quantification of biomarker levels in CSF

  2. Functional Connectivity measures on functional MRI (r)

    Time frame: fMRI will be performed for each participant once during the study (within 3 years of study enrollment).

    Functional Connectivity Measures on fMRI during resting state and task activation

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2017
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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