Vascular Intervention Strategies Trial for Alzheimer's

Phase 2Not Yet RecruitingNCT07447206

University of Southern California10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension Hypercholesterolemia Dementia Risk Factors

Interventions

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).

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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% * ESRD or eGFR \< 20 ml/min /1.73m2 * Does not consent to be contacted or to have their medical record reviewed for research purposes * Concurrent participation in another clinical trial

Locations (1)

Clinical Sciences Building (CSC)

Los Angeles, California, United States

Outcomes

Primary Outcomes

Blood Pressure Control

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

Time frame: Baseline to 6 months

Secondary Outcomes

Lipid Level Changes

Change in LDL cholesterol (mg/dL) from baseline to 6 months.

Time frame: Baseline to 6 months

Feasibility Metrics

adherence to prescribed medications (%).

Time frame: Study duration (6 months)

Central Contacts

Hussein Yassine, MD

CONTACT

(323) 442-0272 hyassine@usc.edu

Data from ClinicalTrials.gov

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