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HEART

CompletedPhase 1 / PHASE2Results posted

Health Evaluation in African Americans Using RAS Therapy

Lead sponsor

Emory University

Asset

telmisartan

Listed sites

1

Recruiting sites

-

Enrollment

61

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Family history of Alzheimer’s disease required

Primary endpoints

•Concentration of Angiotensin Converting Enzyme (ACE 1)•Concentration of Angiotensin Converting Enzyme 2 (ACE 2)•Cerebrospinal Fluid Amyloid β40

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Nih1RF1AG051514
Org study IDIRB00080192
NCT IDNCT02471833

Timeline

Milestones

Study start2015-04actual (month precision)
Study first posted2015-06-15estimated
Primary completion2022-04-15actual
Study completion2022-04-15actual
Last update posted2024-05-23actual
Results first posted2024-05-23actual

Assets

Drug assets

telmisartan

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age30 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (44)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Fluid / digital biomarkers
28
Global cognition
14
Neuroimaging
2

Global cognition

14 endpoints
Primary/protocol endpoint

Concentration of Angiotensin Converting Enzyme (ACE 1)

Time frame:Baseline, Month 8

concentration, descriptive

Primary/protocol endpoint

Concentration of Angiotensin Converting Enzyme 2 (ACE 2)

Time frame:Baseline, Month 8

concentration, descriptive

Primary/protocol endpoint

Cerebrospinal Fluid Amyloid β40

Time frame:Baseline, Month 8

descriptive

Primary/protocol endpoint

Levels of Cerebrospinal Fluid Amyloid β42

Time frame:Baseline, Month 8

concentration, descriptive

Primary/protocol endpoint

Levels of Cerebrospinal Fluid T-tau

Time frame:Baseline, Month 8

concentration, descriptive

Primary/protocol endpoint

Levels of Cerebrospinal Fluid P-tau

Time frame:Baseline, Month 8

concentration, descriptive

Primary/registry result

Concentration of Angiotensin Converting Enzyme (ACE 1)

Time frame:Baseline, Month 8

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
Telmisartan 20mgBaselinen=10 Participants4043.151425.34
Month 8n=7 Participants3305.21764.54
Telmisartan 40mgBaselinen=15 Participants4028.171509.02
Month 8n=12 Participants4102.961498.07
PlaceboBaselinen=16 Participants3836.311627.50
Month 8n=12 Participants3696.711309.61
Primary/registry result

Concentration of Angiotensin Converting Enzyme 2 (ACE 2)

Time frame:Baseline, Month 8

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
Telmisartan 20mgBaselinen=9 Participants889.06870.83
Month 8n=7 Participants231.8647.66
Telmisartan 40mgBaselinen=14 Participants566.43700.13
Month 8n=12 Participants274.1784.74
PlaceboBaselinen=16 Participants783.72998.95
Month 8n=12 Participants264.83109.40
Primary/registry result

Cerebrospinal Fluid Amyloid β40

Time frame:Baseline, Month 8

descriptive

Posted result

GroupValue (mean), picograms per milliliter (pg/mL)Standard deviation
Telmisartan 20mgBaselinen=11 Participants7704.822237.94
Month 8n=9 Participants8011.442688.34
Telmisartan 40mgBaselinen=13 Participants9121.623174.21
Month 8n=12 Participants8820.082514.47
PlaceboBaselinen=16 Participants8259.132176.62
Month 8n=12 Participants8300.672623.31
Primary/registry result

Levels of Cerebrospinal Fluid Amyloid β42

Time frame:Baseline, Month 8

concentration, descriptive

Posted result

GroupValue (mean), pg/mLStandard deviation
Telmisartan 20mgBaselinen=11 Participants611.91138.51
Month 8n=9 Participants620.89256.43
Telmisartan 40mgBaselinen=13 Participants614.54193.54
Month 8n=12 Participants665.42278.00
PlaceboBaselinen=16 Participants578.31190.75
Month 8n=16 Participants599.25204.17
Primary/registry result

Levels of Cerebrospinal Fluid T-tau

Time frame:Baseline, Month 8

concentration, descriptive

Posted result

GroupValue (mean), pg/mLStandard deviation
Telmisartan 20mgBaselinen=11 Participants347.73371.85
Month 8n=9 Participants393.11404.35
Telmisartan 40mgBaselinen=13 Participants281.2389.72
Month 8n=12 Participants266.5883.23
PlaceboBaselinen=16 Participants248.94107.67
Month 8n=12 Participants244.5867.04
Primary/registry result

Levels of Cerebrospinal Fluid P-tau

Time frame:Baseline, Month 8

concentration, descriptive

Posted result

GroupValue (mean), pg/mLStandard deviation
Telmisartan 20mgBaselinen=11 Participants29.7512.88
Month 8n=9 Participants30.4810.16
Telmisartan 40mgBaselinen=13 Participants36.5511.24
Month 8n=12 Participants35.6813.67
PlaceboBaselinen=16 Participants31.5813.24
Month 8n=12 Participants30.4810.30
Other/protocol endpoint

Change in Structural Magnetic Resonance Imaging and White Matter Hyperintensities

Time frame:Baseline, Month 8

change from baseline, improvement

Other_pre_specified/registry result

Change in Structural Magnetic Resonance Imaging and White Matter Hyperintensities

Time frame:Baseline, Month 8

change from baseline, improvement

Neuroimaging

2 endpoints
Other/protocol endpoint

Change in Arterial Spin Labeling-Magnetic Resonance Imaging

Time frame:Baseline, Month 8

change from baseline, improvement

Other_pre_specified/registry result

Change in Arterial Spin Labeling-Magnetic Resonance Imaging

Time frame:Baseline, Month 8

change from baseline, improvement

Fluid / digital biomarkers

28 endpoints
Secondary/protocol endpoint

Interleukin-6 (IL-6) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/protocol endpoint

Interleukin-7 (IL-7) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/protocol endpoint

Interleukin-8 (IL-8) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/protocol endpoint

Interleukin-9 (IL-9) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/protocol endpoint

Interleukin-10 (IL-10) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/protocol endpoint

Monocyte Chemoattractant Protein 1 (MCP-1) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/protocol endpoint

Macrophage Derived Protein 1 (MDC-1) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/protocol endpoint

Transforming Growth Factor Alpha (TGF-α) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/protocol endpoint

Tumor Necrosis Factor Alpha (TNF-α) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/protocol endpoint

Intercellular Adhesion Molecule 1 (ICAM-1) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/protocol endpoint

Vascular Cell Adhesion Molecule 1 (VCAM-1) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/protocol endpoint

Matrix Metalloproteinase (MMP) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/protocol endpoint

Tissue Inhibitor of Metalloproteinase (TIMP) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/protocol endpoint

CSF-Soluble Platelet-Derived Growth Factor Receptor Beta (sPDGFRβ)

Time frame:Baseline, Month 8

descriptive

Secondary/registry result

Interleukin-6 (IL-6) Frequency

Time frame:Baseline, Month 8

event count, event

Posted result

GroupValue (mean), pg/mLStandard deviation
Telmisartan 20mgBaselinen=7 Participants9.413.25
Month 8n=8 Participants8.514.73
Telmisartan 40mgBaselinen=12 Participants10.656.77
Month 8n=12 Participants8.694.14
PlaceboBaselinen=13 Participants8.623.08
Month 8n=12 Participants8.193.23
Secondary/registry result

Interleukin-7 (IL-7) Frequency

Time frame:Baseline, Month 8

event count, event

Posted result

GroupValue (mean), pg/mLStandard deviation
Telmisartan 20mgBaselinen=9 Participants1.881.77
Month 8n=8 Participants2.061.84
Telmisartan 40mgBaselinen=13 Participants1.701.57
Month 8n=12 Participants1.160.66
PlaceboBaselinen=16 Participants1.771.17
Month 8n=12 Participants1.031.01
Secondary/registry result

Interleukin-8 (IL-8) Frequency

Time frame:Baseline, Month 8

event count, event

Posted result

GroupValue (mean), pg/mLStandard deviation
Telmisartan 20mgBaselinen=9 Participants123.7764.31
Month 8n=8 Participants103.3142.88
Telmisartan 40mgBaselinen=13 Participants156.9949.10
Month 8n=12 Participants102.1125.84
PlaceboBaselinen=16 Participants165.40100.25
Month 8n=12 Participants122.9951.36
Secondary/registry result

Interleukin-9 (IL-9) Frequency

Time frame:Baseline, Month 8

event count, event

Posted result

GroupValue (mean), pg/mLStandard deviation
Telmisartan 20mgBaselinen=9 Participants96.5564.31
Month 8n=7 Participants81.2434.06
Telmisartan 40mgBaselinen=13 Participants153.6571.26
Month 8n=12 Participants98.3228.48
PlaceboBaselinen=16 Participants119.1879.53
Month 8n=12 Participants88.2239.96
Secondary/registry result

Interleukin-10 (IL-10) Frequency

Time frame:Baseline, Month 8

event count, event

Posted result

GroupValue (mean), pg/mLStandard deviation
Telmisartan 20mgBaselinen=9 Participants9.703.31
Month 8n=8 Participants8.832.31
Telmisartan 40mgBaselinen=13 Participants11.933.32
Month 8n=12 Participants10.152.85
PlaceboBaselinen=16 Participants10.923.09
Month 8n=12 Participants10.602.26
Secondary/registry result

Monocyte Chemoattractant Protein 1 (MCP-1) Frequency

Time frame:Baseline, Month 8

event count, event

Posted result

GroupValue (mean), pg/mLStandard deviation
Telmisartan 20mgBaselinen=9 Participants3369.301180.22
Month 8n=8 Participants2069.32735.75
Telmisartan 40mgBaselinen=13 Participants3347.26786.79
Month 8n=12 Participants2343.98487.36
PlaceboBaselinen=16 Participants3606.961077.71
Month 8n=12 Participants2548.37872.88
Secondary/registry result

Macrophage Derived Protein 1 (MDC-1) Frequency

Time frame:Baseline, Month 8

event count, event

Posted result

GroupValue (mean), pg/mLStandard deviation
Telmisartan 20mgBaselinen=9 Participants23.6830.61
Month 8n=8 Participants6.704.84
Telmisartan 40mgBaselinen=13 Participants13.1222.27
Month 8n=12 Participants9.475.46
PlaceboBaselinen=16 Participants30.8867.71
Month 8n=12 Participants10.404.41
Secondary/registry result

Transforming Growth Factor Alpha (TGF-α) Frequency

Time frame:Baseline, Month 8

event count, event

Posted result

GroupValue (mean), pg/mLStandard deviation
Telmisartan 20mgBaselinen=9 Participants9.422.29
Month 8n=8 Participants7.562.08
Telmisartan 40mgBaselinen=13 Participants9.581.65
Month 8n=12 Participants7.071.61
PlaceboBaselinen=16 Participants9.051.71
Month 8n=12 Participants7.251.25
Secondary/registry result

Tumor Necrosis Factor Alpha (TNF-α) Frequency

Time frame:Baseline, Month 8

event count, event

Posted result

GroupValue (mean), pg/mLStandard deviation
Telmisartan 20mgBaselinen=9 Participants4.544.12
Month 8n=8 Participants2.960.94
Telmisartan 40mgBaselinen=13 Participants6.724.68
Month 8n=12 Participants3.120.98
PlaceboBaselinen=16 Participants5.173.28
Month 8n=16 Participants4.718.63
Secondary/registry result

Intercellular Adhesion Molecule 1 (ICAM-1) Frequency

Time frame:Baseline, Month 8

event count, event

Posted result

GroupValue (mean), ng/mLStandard deviation
Telmisartan 20mgBaselinen=9 Participants207.81107.74
Month 8n=7 Participants472.01385.47
Telmisartan 40mgBaselinen=13 Participants310.55258.73
Month 8n=12 Participants461.41290.66
PlaceboBaselinen=16 Participants205.18179.56
Month 8n=8 Participants591.69494.44
Secondary/registry result

Vascular Cell Adhesion Molecule 1 (VCAM-1) Frequency

Time frame:Baseline, Month 8

event count, event

Posted result

GroupValue (mean), ng/mLStandard deviation
Telmisartan 20mgBaselinen=9 Participants12585.0410891.20
Month 8n=8 Participants12964.432893.44
Telmisartan 40mgBaselinen=13 Participants16838.799151.95
Month 8n=12 Participants172781.504513.46
PlaceboBaselinen=16 Participants13807.568991.60
Month 8n=12 Participants19212.328557.18
Secondary/registry result

Matrix Metalloproteinase (MMP) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/registry result

Tissue Inhibitor of Metalloproteinase (TIMP) Frequency

Time frame:Baseline, Month 8

event count, event

Secondary/registry result

CSF-Soluble Platelet-Derived Growth Factor Receptor Beta (sPDGFRβ)

Time frame:Baseline, Month 8

descriptive

Posted result

GroupValue (mean), pg/mLStandard deviation
Telmisartan 20mgBaselinen=7 Participants600.30299.60
Month 8n=8 Participants470.93104.50
Telmisartan 40mgBaselinen=12 Participants432.02210.85
Month 8n=12 Participants391.10151.23
PlaceboBaselinen=13 Participants403.74156.44
Month 8n=12 Participants471.60190.34

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.