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Statins

Atorvastatin for Mild Cognitive Impairment

Phase 2
Recruiting
Led By Sevil Yasar, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not taking statins currently or in the last 6 months.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 weeks
Awards & highlights

Study Summary

This trial will test whether atorvastatin can improve blood flow to the brain in people with mild cognitive impairment.

Who is the study for?
This trial is for people with mild cognitive impairment who have memory or other cognitive issues not caused by another neurological disease. Participants should not be diagnosed with dementia, currently taking statins, or have taken them in the last six months. They must also be able to undergo MRI scans.Check my eligibility
What is being tested?
The study tests if Atorvastatin, a medication typically used to lower cholesterol, can improve how well blood vessels in the brain respond and thus potentially increase blood flow in individuals with mild cognitive impairment.See study design
What are the potential side effects?
Atorvastatin may cause muscle pain, fatigue, digestive problems (like constipation or diarrhea), headache, and in rare cases could affect liver function or cause serious muscle damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I haven't taken statins in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain
Secondary outcome measures
Change in cognitive function (domain-specific neurocognitive measure)
Body Weight Changes
Change in plasma exosomes

Trial Design

1Treatment groups
Experimental Treatment
Group I: Atorvastatin 40 mgExperimental Treatment1 Intervention
Participants receive 40 mg atorvastatin orally daily in the evening.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,245 Previous Clinical Trials
14,816,486 Total Patients Enrolled
Sevil Yasar, MD, PhDPrincipal InvestigatorJohns Hopkins University

Media Library

Atorvastatin (Statins) Clinical Trial Eligibility Overview. Trial Name: NCT04765137 — Phase 2
Mild Cognitive Impairment Research Study Groups: Atorvastatin 40 mg
Mild Cognitive Impairment Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT04765137 — Phase 2
Atorvastatin (Statins) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04765137 — Phase 2
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT04765137 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation currently welcome new participants?

"Clinicaltrials.gov confirms that this trial is in active recruitment, having first been made available to the public on May 21st 2021 and last updated October 12th 2022."

Answered by AI

Has a trial of this kind been conducted previously?

"Atorvastatin Oral Tablet is a medication with an extensive research history. Merck Sharp & Dohme LLC initially sponsored the drug's introduction in 2005, where it was tested on 80 participants and subsequently accepted for Phase 4 clinical trials. Currently, there are 70 active studies of Atorvastatin Oral Table spanning 162 cities across 28 countries worldwide."

Answered by AI

Who meets the requirements for inclusion in this research study?

"This medical trial has a limited capacity of 20 participants, aged between 60 and 95 years old, that have been clinically diagnosed with mild cognitive impairment (MCI). Other requirements include evidence suggesting the MCI is not caused by any other neurological conditions or delirium, memory scores lower than 1.5 standard deviations below appropriate norms for their age and education level, no signs of dementia in the patient's history, and an absence of statin usage within the past 6 months."

Answered by AI

What are the known risks associated with Atorvastatin Oral Tablet consumption?

"Based on the evidence provided by phase 2 trials, our team at Power judged Atorvastatin Oral Tablet to be a safe medication with a rating of 2. While there is data affirming safety, efficacy has not yet been established."

Answered by AI

What medical issues does Atorvastatin Oral Tablet typically treat?

"Atorvastatin Oral Tablet is regularly prescribed to treat lipidemias and has been seen to be effective in ameliorating postoperative thromboembolism, anginal pain, transient ischemic attack."

Answered by AI

Does this examination admit participants that are over two decades of age?

"According to the study's inclusion criteria, only people between 60 and 95 years old are eligible. Furthermore, there are 29 trials for minors and 596 for seniors."

Answered by AI

How many individuals are actively participating in this experiment?

"Affirmative, the information publicly available on clinicaltrials.gov shows that this medical trial is currently enrolling patients. This study was originally posted on May 21st 2021 and updated most recently October 12th 2022. The goal is to recruit 20 participants at one site."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Pennsylvania
What site did they apply to?
Johns Hopkins University, Bayview Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I want prevent progression as much as possible.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Johns Hopkins University, Bayview Medical Center: < 48 hours
Average response time
  • < 2 Days
~5 spots leftby Mar 2025