Evaluate the Effect of Atorvastatin on Cerebrovascular Reactivity in Mild Cognitive Impairment (MCI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atorvastatin Oral Tablet.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment. Basic parameters: 60 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Targeting Cerebrovascular Reactivity for Precision Medicine: Pilot Trial of Atorvastatin
Overview
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
- Drug Atorvastatin Oral Tablet
Atorvastatin pill 40 mg to be taken every night
Primary outcome measures
- Change of MRI whole brain cerebrovascular reactivity (wbCVR) [Time frame: Baseline and 12 weeks]
Secondary outcome measures (3)
- Change in plasma exosomes [Time frame: Baseline and 12 weeks]
- Change in cognitive function (global neurocognitive measure) [Time frame: Baseline and 12 weeks]
- Change in cognitive function (domain-specific neurocognitive measure) [Time frame: Baseline and 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Johns Hopkins University, Bayview Medical Center — Baltimore
Identifiers
NCT: NCT04765137 · IRB00256402