Dementia Risk Factors, Hypercholesterolemia, Hypertension
Conditions
Keywords
APOE ε4 carriers, Dementia risk, Hypertension, Hypercholesterolemia, Vascular risk factors, Pharmacist-led intervention, Feasibility study
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.
Interventions
DRUGAngiotensin 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).
DRUGHydrophilic 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.
Sponsors
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Control | Baseline to 6 months | Change in systolic blood pressure (mmHg) from baseline to the end of the 6-month intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid Level Changes | Baseline to 6 months | Change in LDL cholesterol (mg/dL) from baseline to 6 months. |
| Feasibility Metrics | Study duration (6 months) | adherence to prescribed medications (%). |
Countries
United States
Contacts
CONTACTHussein Yassine, MD
Outcome results
None listed