Mild Cognitive ImpairmentNCT05785871
Hypertension, Brain Clearance, and Markers of Neurodegeneration
An observational study of Mild Cognitive Impairment and Hypertension, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this research study is to measure cerebrospinal fluid (CSF) clearance in subjects with and without high blood pressure. CSF cushions the brain from impact and carries waste products from the brain to the bloodstream. This process is known as clearance. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Hypertension
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2020to 30 Jun 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cognitively healthy, with and without hypertension, age 60-80, both men and women
Who may be able to join
- Male and female subjects between 60-80 years old
- All subjects will speak English as their first language or demonstrate proficiency in English.
- All subjects will have normal cognition at baseline: a Clinical dementia rating CDR=0, Global deterioration Scale GDS <2
- For the HTN subjects: systolic HTN defined according to Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood pressure (JNC) 7 report. Specifically: Blood pressure in the ranges greater or equal to 140 mmHG, which is a mean of three seated BP readings on each of two or more office visits
Who cannot join
- Non-essential hypertension
- Diabetes
- Isolated diastolic hypertension
- Neurodegenerative disorders (i.e Parkinson disease)
- Dementia or Mild cognitive impairment at baseline
- Long life major depression. Baseline scores greater or equal to 20 on Beck Depression Inventory at baseline
Show all 9Show fewer
- Long-life DSM-IV axis 1 disorders
- Mental retardation
- Substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to measure cerebrospinal fluid (CSF) clearance in subjects with and without high blood pressure. CSF cushions the brain from impact and carries waste products from the brain to the bloodstream. This process is known as clearance. Impaired removal of proteins from the aging brain causes their buildup and may contribute to an increased risk for Alzheimer's disease. It is also suspected that clearance may be related to the health of vessels carrying the blood throughout the brain. It is known that high blood pressure damages blood vessels and thus may impair clearance. In this project we will examine if having high blood pressure is related to impaired brain clearance and whether treating high blood pressure improves clearance and reduces buildup of Alzheimer's disease-related proteins.
Participants will be asked to undergo a medical examination, testing of memory, brain imaging (both magnetic resonance and positron emission tomography, and spinal tap at the beginning of the study and 1 -2 years later.
Read the detailed description
Over 5 years the investigator will conduct a 24-month longitudinal study of 80 cognitively healthy subjects 60-80 years old, classified at baseline into the following groups: 1) Normotensive NT (n=20), 2) Controlled hypertension C-HTN (n=20), 3) Uncontrolled hypertension or Untreated hypertension UU-HTN (n=30).
For subjects in the NT and C-HTN groups this will be an observational longitudinal study with clinical, imaging and CSF (cerebrospinal fluid) assessment at baseline and 24 month follow-up, with 3 visits to monitor BP (blood pressure) in-between (both at the office and using home BP monitoring). Subjects in the UU-HTN group after having completed their baseline evaluation will be referred for a further evaluation of HTN (hypertension) and an intervention. Intervention: the initiation of treatment or treatment modification to achieve the SBP (systolic blood pressure) goal of <140 mmHg. Subjects will be referred to their physician or, in case they do not have one, to the study cardiologist for treatment according to current guidelines. Imaging at 0 and 24 month consist of MRI (magnetic resonance imaging) with ASL (arterial spin labeling) and brain clearance imaging using 18F-MK6240 PET (positron emission tomography). CSF assessment includes Aβ42 (amyloid beta 42), t-tau (total tau) and p-tau181 (tau phosphorylated at threonine 181).
- Conditions
- Mild Cognitive Impairment, Hypertension
- Medical subject headings
- Cognitive Dysfunction, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Untreated Hypertension | in office SBP ≥140 at two separate occasions and currently treated with antihypertensive medications (uncontrolled), or in office SBP ≥ 140 at two different occasions and no current treatment (untreated). | |
| Normotensive | in office SBP<140 mmHg, no treatment with antihypertensive medications | |
| Controlled Hypertension | in office SBP <140 and current treatment with antihypertensive medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral blood flow
cerebral blood flow with arterial spin labeling MRI
Measured: Baseline and up to 24 month follow up
Change in Brain Clearance
the rate of radiotracer removal from the brain ventricle after injection of MK-6240 images, measured with positron emission tomography
Measured: Baseline and up to 24 month follow up
Change in total tau
total tau protein measured in cerebrospinal fluid
Measured: Baseline and up to 24 month follow up
Change in amyloid 42
amyloid 42 protein measured in cerebrospinal fluid
Measured: Baseline and up to 24 month follow up
Change in cognitive performance
A composite score of tests assessing:
Immediate and delayed memory (score ranges in parentheses):
Craft Story immediate (0-44) and delayed recall (0-44), Guild battery immediate (0-21) and delayed recall (0-21) of paragraph and word pairs immediate (0-10) and delayed (0-10).
Working memory:
Number Span test forward (0-14) and backward (0-14)
Naming:
Verbal Naming Test (0-26).
Attention:
Trail Making Test part A (0-25)
Executive functions:
Trail Making Test Part B (score range 0-13) and Wisconsin Sorting Card Test (0-128).
Verbal Fluency:
Category Fluency: animals (0-30) and vegetables (0-30), category letters F (0-30) and L (0-30).
Each test is transformed into normative z-score. For each domain the scores are expressed as a composite z-score of all the tests assessing a given domain. The score range from -3.0 - to +3.0 higher indicating better performance.
Measured: Baseline and up to 24 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start18 Nov 2020
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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 Weill Medical College of Cornell 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lidia Glodzik, Principal investigator, Weill Cornell MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785871
- Sponsor's protocol ID
- 19-05020073
- Other IDs
- 5R01NS104364-03
- Status last verified
- Aug 2025
- First submitted
- 14 Mar 2023
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participants data will be available after publication of final results.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension, Brain Clearance, and Markers of Neurodegeneration
- ClinicalTrials.gov ID
- NCT05785871
- Acronym / sponsor ID
- 19-05020073
- Conditions
- Mild Cognitive Impairment, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 27 Mar 2023 (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 research study is to measure cerebrospinal fluid (CSF) clearance in subjects with and without high blood pressure. CSF cushions the brain from impact and carries waste products from the brain to the bloodstream. This process is known as clearance. Impaired removal of proteins from the aging brain causes their buildup and may contribute to an increased risk for Alzheimer's disease. It is also suspected that clearance may be related to the health of vessels carrying the blood throughout the brain. It is known that high blood pressure damages blood vessels and thus may impair clearance. In this project we will examine if having high blood pressure is related to impaired brain clearance and whether treating high blood pressure improves clearance and reduces buildup of Alzheimer's disease-related proteins.
Participants will be asked to undergo a medical examination, testing of memory, brain imaging (both magnetic resonance and positron emission tomography, and spinal tap at the beginning of the study and 1 -2 years later.
Detailed description
Over 5 years the investigator will conduct a 24-month longitudinal study of 80 cognitively healthy subjects 60-80 years old, classified at baseline into the following groups: 1) Normotensive NT (n=20), 2) Controlled hypertension C-HTN (n=20), 3) Uncontrolled hypertension or Untreated hypertension UU-HTN (n=30).
For subjects in the NT and C-HTN groups this will be an observational longitudinal study with clinical, imaging and CSF (cerebrospinal fluid) assessment at baseline and 24 month follow-up, with 3 visits to monitor BP (blood pressure) in-between (both at the office and using home BP monitoring). Subjects in the UU-HTN group after having completed their baseline evaluation will be referred for a further evaluation of HTN (hypertension) and an intervention. Intervention: the initiation of treatment or treatment modification to achieve the SBP (systolic blood pressure) goal of <140 mmHg. Subjects will be referred to their physician or, in case they do not have one, to the study cardiologist for treatment according to current guidelines. Imaging at 0 and 24 month consist of MRI (magnetic resonance imaging) with ASL (arterial spin labeling) and brain clearance imaging using 18F-MK6240 PET (positron emission tomography). CSF assessment includes Aβ42 (amyloid beta 42), t-tau (total tau) and p-tau181 (tau phosphorylated at threonine 181).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Untreated Hypertension | – | –in office SBP ≥140 at two separate occasions and currently treated with antihypertensive medications (uncontrolled), or in office SBP ≥ 140 at two different occasions and no current treatment (untreated). |
| Normotensive | – | –in office SBP<140 mmHg, no treatment with antihypertensive medications |
| Controlled Hypertension | – | –in office SBP <140 and current treatment with antihypertensive medications |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cognitively healthy, with and without hypertension, age 60-80, both men and women
Key inclusion criteria (4 listed)
- Male and female subjects between 60-80 years old
- All subjects will speak English as their first language or demonstrate proficiency in English.
- All subjects will have normal cognition at baseline: a Clinical dementia rating CDR=0, Global deterioration Scale GDS <2
- For the HTN subjects: systolic HTN defined according to Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood pressure (JNC) 7 report. Specifically: Blood pressure in the ranges greater or equal to 140 mmHG, which is a mean of three seated BP readings on each of two or more office visits
Key exclusion criteria (9 listed)
- Non-essential hypertension
- Diabetes
- Isolated diastolic hypertension
- Neurodegenerative disorders (i.e Parkinson disease)
- Dementia or Mild cognitive impairment at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in cerebral blood flow
Time frame: Baseline and up to 24 month follow up
cerebral blood flow with arterial spin labeling MRI
Change in Brain Clearance
Time frame: Baseline and up to 24 month follow up
the rate of radiotracer removal from the brain ventricle after injection of MK-6240 images, measured with positron emission tomography
Change in total tau
Time frame: Baseline and up to 24 month follow up
total tau protein measured in cerebrospinal fluid
Change in amyloid 42
Time frame: Baseline and up to 24 month follow up
amyloid 42 protein measured in cerebrospinal fluid
Change in cognitive performance
Time frame: Baseline and up to 24 month follow up
A composite score of tests assessing: Immediate and delayed memory (score ranges in parentheses): Craft Story immediate (0-44) and delayed recall (0-44), Guild battery immediate (0-21) and delayed recall (0-21) of paragraph and word pairs immediate (0-10) and delayed (0-10). Working memory: Number Span test forward (0-14) and backward (0-14) Naming: Verbal Naming Test (0-26). Attention: Trail Making Test part A (0-25) Executive functions: Trail Making Test Part B (score range 0-13) and Wisconsin Sorting Card Test (0-128). Verbal Fluency: Category Fluency: animals (0-30) and vegetables (0-30), category letters F (0-30) and L (0-30). Each test is transformed into normative z-score. For each domain the scores are expressed as a composite z-score of all the tests assessing a given domain. The score range from -3.0 - to +3.0 higher indicating better performance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: Yes. Deidentified participants data will be available after publication of final results.
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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. This study is not recruiting at the moment.
Lidia Glodzik principal investigator
Weill Cornell MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Hypertension, run by Weill Medical College of Cornell 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 27 Aug 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cerebral blood flow (time frame: Baseline and up to 24 month follow up). The study lists 5 primary outcomes in all. 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 27 Aug 2025.