Mild Cognitive Impairment
Conditions
Keywords
Cerebral Vascular Reactivity
Brief summary
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.
Detailed description
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.
Interventions
Atorvastatin pill 40 mg to be taken every night
Sponsors
The Richman Family Precision Medicine Center of Excellence in Alzheimer Disease
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label study with atorvastatin 40 mg
Eligibility
Sex/Gender
ALL
Age
60 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
are chosen to include participants with MCI, enriched for vascular risk factors: * MCI defined by Clinical Dementia Rating (CDR) of 0.5 or 1.0. * Memory, processing speed, executive function, language - cognitive scores \> 1.5 standard deviations below age-education norms. * Not demented by history. * Not taking statins currently or in the last 6 months. * Cognitive/functional impairment not likely due to another neurological disease or delirium.
Exclusion criteria
* Taking a statin currently or have taken a statin in the last 6 months. * Contraindications to taking a statin. * Transplant patient taking cyclosporine. * Unable to undergo MRI procedures (such as having an implanted pacemaker or defibrillator or stimulator or having non MRI compatible metal). * Diagnosis of dementia by history. * Current diagnosis of substance abuse. * History of stroke or myocardial infarction in past 6 months. * History of HIV.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of MRI whole brain cerebrovascular reactivity (wbCVR) | Baseline and 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma exosomes | Baseline and 12 weeks | Endothelial-derived exosomes (EDE) reflect the neurochemistry of cerebrovascular endothelial cells, while neuronal-enriched extracellular vesicles (nEV) are associated with brain white matter hyperintensities. |
| Change in cognitive function (global neurocognitive measure) | Baseline and 12 weeks | Assessed by Global neurocognitive measure. |
| Change in cognitive function (domain-specific neurocognitive measure) | Baseline and 12 weeks | Assessed by Domain-specific neurocognitive measure. |
Countries
United States
Contacts
Primary ContactSamantha Horn
Backup ContactRitu Agarwal
Outcome results
None listed