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Evaluate the Effect of Atorvastatin on Cerebrovascular Reactivity in Mild Cognitive Impairment (MCI)

Johns Hopkins University logo

Johns Hopkins University

Status and phase

Enrolling
Phase 2

Conditions

Mild Cognitive Impairment

Treatments

Drug: Atorvastatin Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT04765137
IRB00256402

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

60 to 95 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Atorvastatin 40 mg
Experimental group
Description:
Participants receive 40 mg atorvastatin orally daily in the evening.
Treatment:
Drug: Atorvastatin Oral Tablet

Trial contacts and locations

1

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Central trial contact

Ritu Agarwal; Samantha Horn

Data sourced from clinicaltrials.gov

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