Vascular Intervention Strategies Trial for Alzheimer's (VISTA)
Vascular Intervention Strategies Trial for Alzheimer's (VISTA)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Hussein Yassine, MD
- Phone Number: (323) 442-0272
- Email: hyassine@usc.edu
Study Locations
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-
California
-
Los Angeles, California, United States, 90033
- Clinical Sciences Building (CSC)
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Pharmacist-Led Vascular Risk Factor Management
Participants receive pharmacist-led management of hypertension and hypercholesterolemia using angiotensin receptor blockers and hydrophilic statins (or non-statin alternatives) over six months.
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Participants receive pharmacist-led management of vascular risk factors over a six-month period.
This includes blood pressure management with angiotensin receptor blockers (ARBs).
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure Control
Time Frame: Baseline to 6 months
|
Change in systolic blood pressure (mmHg) from baseline to the end of the 6-month intervention.
|
Baseline to 6 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lipid Level Changes
Time Frame: Baseline to 6 months
|
Change in LDL cholesterol (mg/dL) from baseline to 6 months.
|
Baseline to 6 months
|
|
Feasibility Metrics
Time Frame: Study duration (6 months)
|
adherence to prescribed medications (%).
|
Study duration (6 months)
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Hyperlipidemias
- Dyslipidemias
- Lipid Metabolism Disorders
- Nutritional and Metabolic Diseases
- Hypertension
- Hypercholesterolemia
- Molecular Mechanisms of Pharmacological Action
- Pharmacologic Actions
- Chemical Actions and Uses
- Angiotensin Receptor Antagonists
Other Study ID Numbers
Other Study ID Numbers
- HS-24-00340
- PG1040967 (Other Grant/Funding Number: University of Southern California)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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