Health Evaluation in African Americans Using RAS Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Concentration of Angiotensin Converting Enzyme 2 (ACE 2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean resting systolic blood pressure ≥ 110 mmHg and ≤ 170 mmHg
- •Family history of Alzheimer's disease
- •African American
排除标准
- •Currently in another investigational drug study
- •Potassium >5.0 meq/dL at baseline
- •Creatinine >1.99 mg/dL at baseline
- •History of stroke or transient ischemic attack (TIA)
- •Current use of a RAS acting medication
- •Contraindication for lumbar puncture or magnetic resonance imaging
- •Heart failure
- •Diabetes Types I and II
- •Pregnant or nursing women
研究组 & 干预措施
Telmisartan 20mg
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who are randomly assigned to receive telmisartan 20mg once a day orally.
干预措施: Telmisartan 20mg (Drug)
Telmisartan 40mg
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who are randomly assigned to receive telmisartan 40mg once a day orally.
干预措施: Telmisartan 40mg (Drug)
Placebo
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who are randomly assigned to receive a placebo to match telmisartan once a day orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Concentration of Angiotensin Converting Enzyme 2 (ACE 2)
时间窗: Baseline, Month 8
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.
Cerebrospinal Fluid Amyloid β40
时间窗: Baseline, Month 8
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.
Levels of Cerebrospinal Fluid P-tau
时间窗: Baseline, Month 8
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.
Levels of Cerebrospinal Fluid T-tau
时间窗: Baseline, Month 8
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.
Concentration of Angiotensin Converting Enzyme (ACE 1)
时间窗: Baseline, Month 8
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.
Levels of Cerebrospinal Fluid Amyloid β42
时间窗: Baseline, Month 8
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.
次要结局
- Transforming Growth Factor Alpha (TGF-α) Frequency(Baseline, Month 8)
- Intercellular Adhesion Molecule 1 (ICAM-1) Frequency(Baseline, Month 8)
- Interleukin-6 (IL-6) Frequency(Baseline, Month 8)
- Interleukin-8 (IL-8) Frequency(Baseline, Month 8)
- Interleukin-9 (IL-9) Frequency(Baseline, Month 8)
- Interleukin-10 (IL-10) Frequency(Baseline, Month 8)
- Matrix Metalloproteinase (MMP) Frequency(Baseline, Month 8)
- CSF-Soluble Platelet-Derived Growth Factor Receptor Beta (sPDGFRβ)(Baseline, Month 8)
- Macrophage Derived Protein 1 (MDC-1) Frequency(Baseline, Month 8)
- Tissue Inhibitor of Metalloproteinase (TIMP) Frequency(Baseline, Month 8)
- Interleukin-7 (IL-7) Frequency(Baseline, Month 8)
- Monocyte Chemoattractant Protein 1 (MCP-1) Frequency(Baseline, Month 8)
- Tumor Necrosis Factor Alpha (TNF-α) Frequency(Baseline, Month 8)
- Vascular Cell Adhesion Molecule 1 (VCAM-1) Frequency(Baseline, Month 8)
研究者
Whitney Wharton
Associate Professor
Emory University