Alzheimer Disease, Late OnsetNCT03300726
Synaptic Injury and Functional Connectivity in Alzheimer's Disease
An observational study of Alzheimer Disease, Late Onset, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Late Onset
- What is being tested?
- CSF analysis and Functional MRI
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2018to 22 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from the community and the Memory Disorders Clinic of The OSU Wexner Medical Center Department of Neurology. This study will include cognitively normal individuals (CDR 0; n=20), individuals with a clinical diagnosis of single-domain or multi-domain amnestic MCI due to AD or mild AD dementia (CDR 0.5 or 1; n=20).
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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Cerebrospinal Fluid Markers of 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).
Read the 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.
- Conditions
- Alzheimer Disease, Late Onset
- Being tested
- CSF analysis, Functional MRI
- Keywords
- Synaptic injury
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF analysisDiagnostic test
CSF analysis for tau, p-tau181, Abeta42, and CSF levels of markers of synaptic injury
Functional MRIRadiation
Functional MRI during resting state and semantic memory task activation
| Study group | Role | What they receive |
|---|---|---|
| MCI due to AD or mild AD dementia | The clinical diagnoses of amnestic MCI due to AD or mild AD dementia will be made according to standard clinical criteria as described by the National Institute of Aging -Alzheimer's Association Working Group and supported by CSF biomarker data for tau, p-tau181, and Aβ42. This includes evaluation for other systemic or neurological disorders which could account for the cognitive impairment, and inclusion of results from ancillary structural imaging (CT or structural MRI), neuro-psychometric testing, and FDG-PET imaging (when available) into the diagnostic scheme. All participants in this group will undergo clinical and cognitive evaluations, CSF analysis, and functional MRI during resting state and semantic memory tasks. Receives: Diagnostic Test: CSF analysis; Radiation: Functional MRI | |
| Normal controls | Normal cognition will be defined as cognitive performance on detailed neuropsychometric testing that falls within 1 SD of age-, gender-, and education-matched norms in all cognitive domains, and no subjective report of cognitive decline from an individual's baseline (i.e. CDR 0). All participants in this group will undergo clinical and cognitive evaluations, CSF analysis, and functional MRI during resting state and semantic memory tasks. Receives: Diagnostic Test: CSF analysis; Radiation: Functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlations between CSF biomarker measurements and fMRI measures of functional connectivity at baseline
Cross-sectional associations between CSF biomarker measurements and fMRI measures at baseline
Measured: 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.
Secondary outcomes (2)
CSF levels of tau, p-tau181, Abeta42, Ng, and SNAP-25 (pg/ml)
Quantification of biomarker levels in CSF
Measured: CSF collection will be performed for each participant once during the study (within 3 years of study enrollment).
Functional Connectivity measures on functional MRI (r)
Functional Connectivity Measures on fMRI during resting state and task activation
Measured: fMRI will be performed for each participant once during the study (within 3 years of study enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start12 Feb 2018
- Primary completion22 Sep 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Late OnsetStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawan Tarawneh, Ohio State University
- Investigators
- Rawan Tarawneh, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300726
- Sponsor's protocol ID
- 2017H0255
- Status last verified
- Sep 2021
- First submitted
- 25 Sep 2017
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrospinal Fluid Markers of Synaptic Injury and Functional Connectivity in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03300726
- Acronym / sponsor ID
- 2017H0255
- Conditions
- Alzheimer Disease, Late Onset
- Keywords
- Synaptic injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI due to AD or mild AD dementia | – | Diagnostic Test: CSF analysis, Radiation: Functional MRIThe clinical diagnoses of amnestic MCI due to AD or mild AD dementia will be made according to standard clinical criteria as described by the National Institute of Aging -Alzheimer's Association Working Group and supported by CSF biomarker data for tau, p-tau181, and Aβ42. This includes evaluation for other systemic or neurological disorders which could account for the cognitive impairment, and inclusion of results from ancillary structural imaging (CT or structural MRI), neuro-psychometric testing, and FDG-PET imaging (when available) into the diagnostic scheme. All participants in this group will undergo clinical and cognitive evaluations, CSF analysis, and functional MRI during resting state and semantic memory tasks. |
| Normal controls | – | Diagnostic Test: CSF analysis, Radiation: Functional MRINormal cognition will be defined as cognitive performance on detailed neuropsychometric testing that falls within 1 SD of age-, gender-, and education-matched norms in all cognitive domains, and no subjective report of cognitive decline from an individual's baseline (i.e. CDR 0). All participants in this group will undergo clinical and cognitive evaluations, CSF analysis, and functional MRI during resting state and semantic memory tasks. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the community and the Memory Disorders Clinic of The OSU Wexner Medical Center Department of Neurology. This study will include cognitively normal individuals (CDR 0; n=20), individuals with a clinical diagnosis of single-domain or multi-domain amnestic MCI due to AD or mild AD dementia (CDR 0.5 or 1; n=20).
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 |
|---|---|---|
| CSF analysisCSF analysis for tau, p-tau181, Abeta42, and CSF levels of markers of synaptic injury | Diagnostic test | MCI due to AD or mild AD dementia, Normal controls |
| Functional MRIFunctional MRI during resting state and semantic memory task activation | Radiation | MCI due to AD or mild AD dementia, Normal controls |
Primary outcome
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
2 secondary outcomes
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Rawan Tarawneh, MD principal investigator
Ohio State University
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 Alzheimer Disease, Late Onset, run by Ohio State University 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?
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 28 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). 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 28 Sep 2021.