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Not yet recruiting NCT07447206

Vascular Intervention Strategies Trial for Alzheimer's

Phase II Interventional Hypertension Hypercholesterolemia Dementia Risk Factors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Angiotensin Receptor Blockers (ARBs), Hydrophilic Statins or Non-Statin Alternative.
Who it may be relevant to
Registry conditions: Hypertension, Hypercholesterolemia, Dementia Risk Factors. Basic parameters: 50 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Vascular Intervention Strategies Trial for Alzheimer's (VISTA)

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.

Interventions

  • Drug Angiotensin Receptor Blockers (ARBs)
    Participants receive pharmacist-led management of vascular risk factors over a six-month period. This includes blood pressure management with angiotensin receptor blockers (ARBs).
  • Drug Hydrophilic Statins or Non-Statin Alternative
    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.

Primary outcome measures

  • Blood Pressure Control [Time frame: Baseline to 6 months]
Secondary outcome measures (2)
  • Lipid Level Changes [Time frame: Baseline to 6 months]
  • Feasibility Metrics [Time frame: Study duration (6 months)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Clinical Sciences Building (CSC) — Los Angeles

Identifiers

NCT: NCT07447206 · HS-24-00340 · PG1040967

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗