Alzheimer Disease, Late Onset Clinical Trial
Official title:
Cerebrospinal Fluid Markers of Synaptic Injury and Functional Connectivity in Alzheimer's Disease
Verified date | September 2021 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 35 |
Est. completion date | September 22, 2021 |
Est. primary completion date | September 22, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 95 Years |
Eligibility | Inclusion Criteria: Participants included in the study should meet all 4 inclusion criteria: 1. 60 years of age or older 2. A clinical diagnosis of MCI, mild AD dementia, or normal cognition 3. No significant medical or surgical co-morbidities 4. No contraindications to LP or MRI. Exclusion criteria: Participants with any of the following criteria will be excluded from the study: 1. 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 2. Individuals with any past history of ischemic or traumatic brain injury 3. Individuals with imaging evidence of significant cerebrovascular disease or structural brain lesions (e.g. tumor, demyelinating disorders, infection, or congenital anomalies) 4. Active mood disorder 5. Active alcohol use 6. Active use of benzodiazepines, barbiturates, anticholinergic, or anti-epileptic medications |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | CSF levels of tau, p-tau181, Abeta42, Ng, and SNAP-25 (pg/ml) | Quantification of biomarker levels in CSF | CSF collection will be performed for each participant once during the study (within 3 years of study enrollment). | |
Secondary | Functional Connectivity measures on functional MRI (r) | Functional Connectivity Measures on fMRI during resting state and task activation | fMRI will be performed for each participant once during the study (within 3 years of study enrollment). |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05407272 -
Explore the Sharing Model Intervene to Improve the Knowledge, Attitudes, Service Intentions and Service Start-up Effects of the Eight Major Non-cancer Disease End-stage Caregivers on Well-being and Palliative Care
|
N/A | |
Completed |
NCT02958930 -
Safety and Efficacy of Transcranial Electromagnetic Treatment Against Alzheimer's Disease
|
N/A | |
Completed |
NCT04449926 -
BCG and Plasma Amyloid in Non-Demented Adults
|
Phase 2 | |
Recruiting |
NCT06203106 -
NYSCF Scientific Discovery Biobank
|
||
Active, not recruiting |
NCT03661034 -
Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
|
N/A | |
Not yet recruiting |
NCT05183516 -
Tdap and Biomarkers of Alzheimer's Disease
|
Phase 1/Phase 2 | |
Recruiting |
NCT04263194 -
Network-based rTMS in Alzheimer's Disease
|
N/A | |
Recruiting |
NCT04100889 -
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease
|
||
Completed |
NCT02187276 -
The Predictive Factors of Good Clinical Response to Cholinesterase Inhibitors in Alzheimer Disease and Mixed Dementia
|
N/A | |
Recruiting |
NCT04680013 -
Genetic Studies in Familial Dementia
|
||
Recruiting |
NCT04270474 -
Reducing Risk of Dementia Through Deprescribing
|
N/A | |
Not yet recruiting |
NCT06448403 -
Multimodal Assesment of Alzheimer Patients
|
||
Enrolling by invitation |
NCT06078891 -
Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease?
|
Early Phase 1 | |
Recruiting |
NCT05138848 -
Time-in-bed Restriction in Older Adults With Sleep Difficulties With and Without Risk for Alzheimer's Disease
|
N/A | |
Withdrawn |
NCT03149380 -
Effectiveness of Alzheimer's Universe (Www.AlzU.Org) on Knowledge and Behavior
|
N/A | |
Recruiting |
NCT03653156 -
China Cognition and Aging Study
|
||
Recruiting |
NCT01773915 -
New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study
|
N/A | |
Recruiting |
NCT05655195 -
Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy
|
N/A | |
Recruiting |
NCT05637801 -
A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)
|
N/A | |
Recruiting |
NCT03153371 -
Early-onset Alzheimer's Disease Phenotypes: Neuropsychology and Neural Networks
|