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| Name | Class |
|---|---|
| The Richman Family Precision Medicine Center of Excellence in Alzheimer Disease | UNKNOWN |
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The purpose of this study is to evaluate the effect of atorvastatin on brain vessel reactivity and with it on blood flow in people with mild cognitive impairment.
Participants are first being informed about potential benefits and risks of the study and are required to give written consent. After that participants will undergo detailed phone screen to determine eligibility for study entry. At week 0, participants who meet eligibility requirements will be prescribed atorvastatin (40 mg, once in the evening) in an open-label manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin 40 mg | Experimental | Participants receive 40 mg atorvastatin orally daily in the evening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin Oral Tablet | Drug | Atorvastatin pill 40 mg to be taken every night |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of MRI whole brain cerebrovascular reactivity (wbCVR) | MRI based CVR is a newer technique that measures dilatory function of the microvessels which have been shown to be superior to measurement of Cerebral blood flow (CBF) and have also been shown to be low in participants with MCI. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma exosomes | Endothelial-derived exosomes (EDE) reflect the neurochemistry of cerebrovascular endothelial cells, while neuronal-enriched extracellular vesicles (nEV) are associated with brain white matter hyperintensities. | Baseline and 12 weeks |
| Change in cognitive function (global neurocognitive measure) |
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Inclusion Criteria are chosen to include participants with MCI, enriched for vascular risk factors:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha Horn | Contact | 410-550-9020 | shorn8@jhmi.edu | |
| Ritu Agarwal | Contact | 410-550-9020 | ragarw19@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul Rosenberg, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University, Bayview Medical Center | Recruiting | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Open-label study with atorvastatin 40 mg
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Assessed by Global neurocognitive measure. |
| Baseline and 12 weeks |
| Change in cognitive function (domain-specific neurocognitive measure) | Assessed by Domain-specific neurocognitive measure. | Baseline and 12 weeks |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |