NCT07447206

Brief Summary

The proposed pharmacist-led study is a feasibility pilot trial for the management of vascular risk factors of hypertension and hypercholesterolemia in 10 APOE ε4 carriers, 50-75, at-risk for dementia. All participants will receive angiotensin receptor blockers (ARBs) for high blood pressure, and hydrophilic statins (or a non-statin alternative) for high cholesterol over a six-month period.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2 hypertension

Timeline
23mo left

Started May 2026

Typical duration for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
May 2026Jun 2028

First Submitted

Initial submission to the registry

February 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

February 25, 2026

Last Update Submit

April 27, 2026

Conditions

HypertensionHypercholesterolemiaDementia Risk Factors

Keywords

APOE ε4 carriersDementia riskHypertensionHypercholesterolemiaVascular risk factorsPharmacist-led interventionFeasibility study

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure Control

    Change in systolic blood pressure (mmHg) from baseline to the end of the 6-month intervention.

    Baseline to 6 months

Secondary Outcomes (2)

  • Lipid Level Changes

    Baseline to 6 months

  • Feasibility Metrics

    Study duration (6 months)

Study Arms (1)

Pharmacist-Led Vascular Risk Factor Management

EXPERIMENTAL

Participants receive pharmacist-led management of hypertension and hypercholesterolemia using angiotensin receptor blockers and hydrophilic statins (or non-statin alternatives) over six months.

Drug: Angiotensin Receptor Blockers (ARBs)Drug: Hydrophilic Statins or Non-Statin Alternative

Interventions

Hydrophilic Statins or Non-Statin AlternativeDRUG

Participants receive pharmacist-led management of vascular risk factors over a six-month period. This includes cholesterol management with hydrophilic statins or a non-statin alternative if statins are not appropriate.

Pharmacist-Led Vascular Risk Factor Management
Angiotensin Receptor Blockers (ARBs)DRUG

Participants receive pharmacist-led management of vascular risk factors over a six-month period. This includes blood pressure management with angiotensin receptor blockers (ARBs).

Pharmacist-Led Vascular Risk Factor Management

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • APOE ε4 carrier (homozygote or heterozygote)
  • LDL-C of 100-250 mg/dL
  • Systolic blood Pressure (SBP) 130-180 mm Hg
  • Age 50-75 years
  • Fluency in English
  • No dementia based on medical record review
  • Male or post-menopausal female

You may not qualify if:

  • One minute standing SBP \< 110 mm Hg
  • Arm circumference prevents from accurate BP measurement with use of available devices
  • Lost weight of \> 10% unintendedly (within the past 6 months),
  • Contraindications to blood pressure and cholesterol lowering medications
  • Use of medications prescribed for dementia (e.g., aducanumab, donanemab, lecanemab, donepezil, galantamine, rivastigmine, memantine)
  • Evidence of dementia based on medical record review
  • Living in a skilled nursing or rehabilitation facility
  • Receiving palliative or hospice care
  • Bipolar illness or schizophrenia
  • Drug or alcohol disorder
  • Receiving chronic opioid therapy
  • Any significant neurological disease (e.g., Parkinson's disease, amyotrophic lateral sclerosis, or multiple sclerosis)
  • Severe loss of visual, hearing or communication ability
  • Organ transplant
  • History of stroke, symptomatic HF or left ventricular ejection fraction \< 35%
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Sciences Building (CSC)

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

HypertensionHypercholesterolemia

Interventions

Angiotensin Receptor Antagonists

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Hussein Yassine, MD

CONTACT

(323) 442-0272hyassine@usc.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology and Department of Physiology and Neuroscience; Kenneth and Bette Volk Professorship in Neurology; Director, Center for Personalized Brain Health

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)