Targeting Cerebrovascular Reactivity for Precision Medicine: Pilot Trial of Atorvastatin
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change of MRI whole brain cerebrovascular reactivity (wbCVR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
- •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.
Arms & Interventions
Atorvastatin 40 mg
Participants receive 40 mg atorvastatin orally daily in the evening.
Intervention: Atorvastatin Oral Tablet (Drug)
Outcomes
Primary Outcomes
Change of MRI whole brain cerebrovascular reactivity (wbCVR)
Time Frame: 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 Outcomes
- Change in cognitive function (global neurocognitive measure)(Baseline and 12 weeks)
- Change in plasma exosomes(Baseline and 12 weeks)
- Change in cognitive function (domain-specific neurocognitive measure)(Baseline and 12 weeks)