The purpose of this study is to determine if telmisartan, an FDA approved blood pressure medication, may also have beneficial effects on Alzheimer's disease prevention in African Americans, who are at high risk for Alzheimer's disease.
This study will assess if telmisartan, an FDA approved blood pressure medication, may also have beneficial effects on Alzheimer's disease (AD) prevention in African Americans, who are at high risk for Alzheimer's disease. Blood pressure medications known as angiotensin-receptor blockers have been associated with reduced risk of Alzheimer's in Caucasians because they act on the renin-angiotensin system (RAS), a key regulator of blood pressure in the body and the brain. The drugs appear to slow the progression of the disease by affecting flow of blood and the amount of plaque in the brain, but these benefits have not been tested in African Americans. The investigator will evaluate if telmisartan is able to influence the renin-angiotensin system in the brain and produce favorable effects on brain blood flow and enzymes that cause the brain plaques in Alzheimer's disease.The investigator will assess the mechanism by which telmisartan modifies the brain renin angiotensin system, cerebrospinal fluid amyloid-β, cerebral blood flow (CBF) and inflammatory markers in hypertensive African Americans.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
61
Participants will be given 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
Participants will be given 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
Participants will be given placebo to be taken orally once a day before bedtime, for a duration of 8 months.
Emory University
Atlanta, Georgia, United States
Concentration of Angiotensin Converting Enzyme (ACE 1)
The cerebrospinal fluid renin-angiotensin system (RAS) was assessed by measuring levels of angiotensin metabolites in a 1 milliliter (mL) sample of cerebrospinal fluid (CSF). ACE 1 helps to regulate blood pressure by converting angiotensin I to angiotensin II.
Time frame: Baseline, Month 8
Concentration of Angiotensin Converting Enzyme 2 (ACE 2)
The cerebrospinal fluid renin-angiotensin system (RAS) was assessed by measuring levels of angiotensin metabolites in a 1 milliliter (mL) sample of cerebrospinal fluid (CSF). ACE 2 regulates levels of circulating angiotensin II. ACE 2 increases during illness and with Alzheimer's disease.
Time frame: Baseline, Month 8
Cerebrospinal Fluid Amyloid β40
Levels of amyloid β40 (Aβ40) in the cerebrospinal fluid were measured using LUMIPULSE® technology. The relationship between Aβ40 is non-linear with moderate levels showing the highest risk of future cognitive decline in some studies.
Time frame: Baseline, Month 8
Levels of Cerebrospinal Fluid Amyloid β42
Levels of amyloid β42 (Aβ42) in the cerebrospinal fluid were measured using LUMIPULSE® technology. Decreases in concentrations of amyloid β42 are indicative of a decrease in cognitive function.
Time frame: Baseline, Month 8
Levels of Cerebrospinal Fluid T-tau
Levels of T-tau in the cerebrospinal fluid were measured using LUMIPULSE® technology. Increases in concentrations of T-tau are indicative of a decrease in cognitive function.
Time frame: Baseline, Month 8
Levels of Cerebrospinal Fluid P-tau
Levels of P-tau in the cerebrospinal fluid were measured using LUMIPULSE® technology. Increases in concentrations of P-tau are indicative of a decrease in cognitive function.
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Time frame: Baseline, Month 8
Interleukin-6 (IL-6) Frequency
The inflammatory marker IL-6 in CSF was examined.
Time frame: Baseline, Month 8
Interleukin-7 (IL-7) Frequency
The inflammatory marker IL-7 in CSF was examined.
Time frame: Baseline, Month 8
Interleukin-8 (IL-8) Frequency
The inflammatory marker IL-8 in CSF was examined.
Time frame: Baseline, Month 8
Interleukin-9 (IL-9) Frequency
The inflammatory marker IL-9 in CSF was examined.
Time frame: Baseline, Month 8
Interleukin-10 (IL-10) Frequency
The inflammatory marker IL-10 in CSF was examined.
Time frame: Baseline, Month 8
Monocyte Chemoattractant Protein 1 (MCP-1) Frequency
Monocyte chemoattractant protein 1 inflammatory markers in CSF were examined.
Time frame: Baseline, Month 8
Macrophage Derived Protein 1 (MDC-1) Frequency
Macrophage derived protein 1 inflammatory markers in CSF were examined.
Time frame: Baseline, Month 8
Transforming Growth Factor Alpha (TGF-α) Frequency
Transforming growth factor alpha inflammatory markers in CSF were examined.
Time frame: Baseline, Month 8
Tumor Necrosis Factor Alpha (TNF-α) Frequency
Tumor necrosis factor alpha inflammatory markers in CSF were examined.
Time frame: Baseline, Month 8
Intercellular Adhesion Molecule 1 (ICAM-1) Frequency
Intercellular adhesion molecule 1 inflammatory markers in CSF were examined.
Time frame: Baseline, Month 8
Vascular Cell Adhesion Molecule 1 (VCAM-1) Frequency
Vascular cell adhesion molecule 1 inflammatory markers in CSF were examined.
Time frame: Baseline, Month 8
Matrix Metalloproteinase (MMP) Frequency
Matrix metalloproteinase inflammatory markers will be examined in CSF.
Time frame: Baseline, Month 8
Tissue Inhibitor of Metalloproteinase (TIMP) Frequency
Tissue inhibitor of metalloproteinase inflammatory markers will be examined in CSF.
Time frame: Baseline, Month 8
CSF-Soluble Platelet-Derived Growth Factor Receptor Beta (sPDGFRβ)
Soluble Platelet-Derived Growth Factor Receptor Beta (sPDGFRβ) is a marker of breakdown in the blood brain barrier. Increased levels of sPDGFRβ indicate cognitive dysfunction.
Time frame: Baseline, Month 8