Mild Cognitive ImpairmentPhase 2NCT04765137
Evaluate the Effect of Atorvastatin on Cerebrovascular Reactivity in Mild Cognitive Impairment (MCI)
A Phase 2 study testing Atorvastatin Oral Tablet in people with Mild Cognitive Impairment, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Atorvastatin Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2021to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University, Bayview Medical Center
Baltimore, Maryland, 21224
Samantha Horn, 410-550-9020, shorn8@jhmi.edu
Ritu Agarwal, 410-550-9020, ragarw19@jhmi.edu
About this study
Official title: Targeting Cerebrovascular Reactivity for Precision Medicine: Pilot Trial of Atorvastatin
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Atorvastatin Oral Tablet
- Keywords
- Cerebral Vascular Reactivity
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin Oral TabletDrug
Also called Lipitor oral tablet
Atorvastatin pill 40 mg to be taken every night
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin 40 mg | Experimental | Participants receive 40 mg atorvastatin orally daily in the evening. Receives: Drug: Atorvastatin Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of MRI whole brain cerebrovascular reactivity (wbCVR)
MRI based CVR is a newer technique that measures dilatory function of the microvessels which have been shown to be superior to measurement of Cerebral blood flow (CBF) and have also been shown to be low in participants with MCI.
Measured: Baseline and 12 weeks
Secondary outcomes (3)
Change in plasma exosomes
Endothelial-derived exosomes (EDE) reflect the neurochemistry of cerebrovascular endothelial cells, while neuronal-enriched extracellular vesicles (nEV) are associated with brain white matter hyperintensities.
Measured: Baseline and 12 weeks
Change in cognitive function (global neurocognitive measure)
Assessed by Global neurocognitive measure.
Measured: Baseline and 12 weeks
Change in cognitive function (domain-specific neurocognitive measure)
Assessed by Domain-specific neurocognitive measure.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start21 May 2021
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label study with atorvastatin 40 mg
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- The Richman Family Precision Medicine Center of Excellence in Alzheimer Disease
- Responsible party
- Sponsor
- Investigators
- Paul Rosenberg, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765137
- Sponsor's protocol ID
- IRB00256402
- Status last verified
- Jul 2026
- First submitted
- 18 Feb 2021
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Cerebrovascular Reactivity for Precision Medicine: Pilot Trial of Atorvastatin
- ClinicalTrials.gov ID
- NCT04765137
- Acronym / sponsor ID
- IRB00256402
- Conditions
- Mild Cognitive Impairment
- Keywords
- Cerebral Vascular Reactivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- The Richman Family Precision Medicine Center of Excellence in Alzheimer Disease
- Study start
- 21 May 2021 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label study with atorvastatin 40 mg
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin 40 mg | Experimental | Drug: Atorvastatin Oral TabletParticipants receive 40 mg atorvastatin orally daily in the evening. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin Oral TabletAlso: Lipitor oral tabletAtorvastatin pill 40 mg to be taken every night | Drug | Atorvastatin 40 mg |
Primary outcome
Change of MRI whole brain cerebrovascular reactivity (wbCVR)
Time frame: Baseline and 12 weeks
MRI based CVR is a newer technique that measures dilatory function of the microvessels which have been shown to be superior to measurement of Cerebral blood flow (CBF) and have also been shown to be low in participants with MCI.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Rosenberg, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin Oral Tablet in people with Mild Cognitive Impairment, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Horn (410-550-9020, shorn8@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of MRI whole brain cerebrovascular reactivity (wbCVR) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.