NCT04765137PHASE2RecruitingAccepts Healthy Volunteers
Evaluate the Effect of Atorvastatin on Cerebrovascular Reactivity in Mild Cognitive Impairment (MCI)
Johns Hopkins University
Start Date
5/21/2021
Completion Date
12/31/2027
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.
Eligibility Criteria
Age Range: 60 years to 95 years
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.
Interventions
DRUG
Atorvastatin Oral Tablet
Conditions
Mild Cognitive Impairment
Locations
Johns Hopkins University, Bayview Medical Center
Baltimore, Maryland 21224
United States