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Statins
Atorvastatin for Mild Cognitive Impairment
Phase 2
Recruiting
Led By Paul Rosenberg, MD
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
Must not have
Taking a statin currently or have taken a statin in the last 6 months.
Contraindications to taking a statin.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 weeks
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I haven't taken statins in the last 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking or have taken a statin in the past 6 months.
Select...
I cannot take statin medications due to health reasons.
Select...
I am a transplant patient on cyclosporine.
Select...
I have a history of HIV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brain
Secondary study objectives
Change in cognitive function (domain-specific neurocognitive measure)
Body Weight Changes
Change in plasma exosomes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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?
The Richman Family Precision Medicine Center of Excellence in Alzheimer DiseaseUNKNOWN
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,653 Total Patients Enrolled
Paul Rosenberg, MDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
246 Total Patients Enrolled
Sevil Yasar, MD, PhDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with dementia in the past or have a history of dementia.I haven't taken statins in the last 6 months.I am a transplant patient on cyclosporine.I have not had a stroke or heart attack in the last 6 months.Your cognitive test scores for memory, processing speed, executive function, and language are very low (more than 1.5 standard deviations below normal for your age and education).I am currently taking or have taken a statin in the past 6 months.You do not have cognitive or functional impairment caused by another neurological disease or confusion.You currently have a problem with drugs or alcohol.I have a history of HIV.You have mild cognitive impairment, which is when your ability to think and remember things is slightly reduced.You cannot have an MRI because you have a pacemaker, defibrillator, or other metal implants that are not compatible.I cannot take statin medications due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Atorvastatin 40 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT04765137 — Phase 2