Phase 2
Completed N=61
Health Evaluation in African Americans Using RAS Therapy
Source: ClinicalTrials.gov NCT02471833 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Concentration of Angiotensin Converting Enzyme (ACE 1) — 4043.15; 4028.17; 3836.31; 3305.21 ng/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Angiotensin Converting Enzyme (ACE 1) |
4043.15; 4028.17; 3836.31; 3305.21; 4102.96; 3696.71 | — |
| PRIMARY Concentration of Angiotensin Converting Enzyme 2 (ACE 2) |
889.06; 566.43; 783.72; 231.86; 274.17; 264.83 | — |
| PRIMARY Cerebrospinal Fluid Amyloid β40 |
7704.82; 9121.62; 8259.13; 8011.44; 8820.08; 8300.67 | — |
| PRIMARY Levels of Cerebrospinal Fluid Amyloid β42 |
611.91; 614.54; 578.31; 620.89; 665.42; 599.25 | — |
| PRIMARY Levels of Cerebrospinal Fluid T-tau |
347.73; 281.23; 248.94; 393.11; 266.58; 244.58 | — |
| PRIMARY Levels of Cerebrospinal Fluid P-tau |
29.75; 36.55; 31.58; 30.48; 35.68; 30.48 | — |
| SECONDARY Interleukin-6 (IL-6) Frequency |
9.41; 10.65; 8.62; 8.51; 8.69; 8.19 | — |
| SECONDARY Interleukin-7 (IL-7) Frequency |
1.88; 1.70; 1.77; 2.06; 1.16; 1.03 | — |
| SECONDARY Interleukin-8 (IL-8) Frequency |
123.77; 156.99; 165.40; 103.31; 102.11; 122.99 | — |
| SECONDARY Interleukin-9 (IL-9) Frequency |
96.55; 153.65; 119.18; 81.24; 98.32; 88.22 | — |
| SECONDARY Interleukin-10 (IL-10) Frequency |
9.70; 11.93; 10.92; 8.83; 10.15; 10.60 | — |
| SECONDARY Monocyte Chemoattractant Protein 1 (MCP-1) Frequency |
3369.30; 3347.26; 3606.96; 2069.32; 2343.98; 2548.37 | — |
| SECONDARY Macrophage Derived Protein 1 (MDC-1) Frequency |
23.68; 13.12; 30.88; 6.70; 9.47; 10.40 | — |
| SECONDARY Transforming Growth Factor Alpha (TGF-α) Frequency |
9.42; 9.58; 9.05; 7.56; 7.07; 7.25 | — |
| SECONDARY Tumor Necrosis Factor Alpha (TNF-α) Frequency |
4.54; 6.72; 5.17; 2.96; 3.12; 4.71 | — |
| SECONDARY Intercellular Adhesion Molecule 1 (ICAM-1) Frequency |
207.81; 310.55; 205.18; 472.01; 461.41; 591.69 | — |
| SECONDARY Vascular Cell Adhesion Molecule 1 (VCAM-1) Frequency |
12585.04; 16838.79; 13807.56; 12964.43; 172781.50; 19212.32 | — |
| SECONDARY Matrix Metalloproteinase (MMP) Frequency |
— | — |
| SECONDARY Tissue Inhibitor of Metalloproteinase (TIMP) Frequency |
— | — |
| SECONDARY CSF-Soluble Platelet-Derived Growth Factor Receptor Beta (sPDGFRβ) |
600.30; 432.02; 403.74; 470.93; 391.10; 471.60 | — |
Eligibility Criteria
Inclusion Criteria
- Mean resting systolic blood pressure ≥ 110 mmHg and ≤ 170 mmHg
- Family history of Alzheimer's disease
- African American
Exclusion Criteria
- 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)
- Dementia
- 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
Data sourced from ClinicalTrials.gov (NCT02471833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.