Vascular Intervention Strategies Trial for Alzheimer's

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-75
SponsorUniversity of Southern California

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 Alternative

    Drug

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Pharmacist-Led Vascular Risk Factor ManagementExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

1

Lipid Level Changes

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

Time frame
Baseline to 6 months
2

Feasibility Metrics

adherence to prescribed medications (%).

Time frame
Study duration (6 months)

Other outcomes

Sponsors and contacts

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