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| ID | Type | Description | Link |
|---|---|---|---|
| 1RF1AG051514 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan 20mg | Experimental | 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. |
|
| Telmisartan 40mg | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan 20mg | Drug | Participants will be given 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Baseline, Month 8 |
| Levels of Cerebrospinal Fluid P-tau |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin-6 (IL-6) Frequency | The inflammatory marker IL-6 in CSF was examined. | Baseline, Month 8 |
| Interleukin-7 (IL-7) Frequency | The inflammatory marker IL-7 in CSF was examined. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Structural Magnetic Resonance Imaging and White Matter Hyperintensities | High-resolution anatomical images will be acquired using a 3D-Fast Spoiled Gradient Recalled Echo (FSPGR) Sequence. White Matter Hyperintensities (WMH) will be identified by a 3D T2 Fluid Attenuated Inversion Recovery (FLAIR) Fast Spin Echo sequence. The images will be co-registered using a within-subject inter-modal alignment between structural and perfusion images. T1-weighted Spoiled Gradient Recalled (SPGR) images will be used to identify cerebrospinal fluid and white and gray matter. Increased volumes of white matter hyperintensities indicate impaired cognitive function. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Whitney Whitney, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29254080 | Background | Wharton W, Goldstein FC, Tansey MG, Brown AL, Tharwani SD, Verble DD, Cintron A, Kehoe PG. Rationale and Design of the Mechanistic Potential of Antihypertensives in Preclinical Alzheimer's (HEART) Trial. J Alzheimers Dis. 2018;61(2):815-824. doi: 10.3233/JAD-161198. |
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Participants were recruited from the Wesley Woods Health Center, Emory Alzheimer's Clinical Research Unit (ACRU), and the Emory Brain Health Center in Atlanta, Georgia, USA. Participant enrollment began April 2015 and all follow-up assessments were completed by April 15, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Telmisartan 20mg | African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease (AD) who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. |
| FG001 | Telmisartan 40mg | African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. |
| FG002 | Placebo | African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telmisartan 20mg | African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. |
| BG001 | Telmisartan 40mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Month 8 |
|
Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telmisartan 20mg | African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
Unanticipated expenses related to the Coronavirus Disease 2019 (COVID-19) pandemic resulted in less funds toward the end of this study impacting the post processing of neuroimaging scans.The researchers are submitting for additional funding for imaging processing and analyses, as well as searching for an expert who is available to perform imaging processing. Results for the magnetic resonance imaging outcomes will be reported as soon as possible.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Whitney Wharton, PhD | Emory University | 404-712-7359 | w.wharton@emory.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2022 | Apr 8, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 13, 2021 | Apr 6, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D006973 | Hypertension |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Telmisartan 40mg | Drug | Participants will be given 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. |
|
|
| Placebo | Drug | Participants will be given placebo to be taken orally once a day before bedtime, for a duration of 8 months. |
|
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.
| Baseline, Month 8 |
| Baseline, Month 8 |
| Interleukin-8 (IL-8) Frequency | The inflammatory marker IL-8 in CSF was examined. | Baseline, Month 8 |
| Interleukin-9 (IL-9) Frequency | The inflammatory marker IL-9 in CSF was examined. | Baseline, Month 8 |
| Interleukin-10 (IL-10) Frequency | The inflammatory marker IL-10 in CSF was examined. | Baseline, Month 8 |
| Monocyte Chemoattractant Protein 1 (MCP-1) Frequency | Monocyte chemoattractant protein 1 inflammatory markers in CSF were examined. | Baseline, Month 8 |
| Macrophage Derived Protein 1 (MDC-1) Frequency | Macrophage derived protein 1 inflammatory markers in CSF were examined. | Baseline, Month 8 |
| Transforming Growth Factor Alpha (TGF-α) Frequency | Transforming growth factor alpha inflammatory markers in CSF were examined. | Baseline, Month 8 |
| Tumor Necrosis Factor Alpha (TNF-α) Frequency | Tumor necrosis factor alpha inflammatory markers in CSF were examined. | Baseline, Month 8 |
| Intercellular Adhesion Molecule 1 (ICAM-1) Frequency | Intercellular adhesion molecule 1 inflammatory markers in CSF were examined. | Baseline, Month 8 |
| Vascular Cell Adhesion Molecule 1 (VCAM-1) Frequency | Vascular cell adhesion molecule 1 inflammatory markers in CSF were examined. | Baseline, Month 8 |
| Matrix Metalloproteinase (MMP) Frequency | Matrix metalloproteinase inflammatory markers will be examined in CSF. | Baseline, Month 8 |
| Tissue Inhibitor of Metalloproteinase (TIMP) Frequency | Tissue inhibitor of metalloproteinase inflammatory markers will be examined in CSF. | 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. | Baseline, Month 8 |
| Baseline, Month 8 |
| Change in Arterial Spin Labeling-Magnetic Resonance Imaging | Echoplanar T1 mapping scans will be used for image registration and a scout image of the head will be obtained in order to choose the appropriate location for spin labeling and flow imaging. Arterial Spin Labeling images will be acquired using a custom 3D stack of interleaved spirals fast spin echo sequences and will be averaged in order to improve the signal-to-noise ratio. Images will be interpolated and smoothed in a panel by using a 0.5-pixel, full-width, half-maximum Gaussian kernel. Regional perfusion will be quantified in each hemisphere and maps of cerebral vasoreactivity will be obtained by co-registration of perfusion and anatomical images. | Baseline, Month 8 |
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. |
| BG002 | Placebo | African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Telmisartan 40mg | African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. |
| OG002 | Placebo | African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. |
|
|
| Primary | 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. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Month 8 |
|
|
|
| Primary | 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. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | picograms per milliliter (pg/mL) | Baseline, Month 8 |
|
|
|
| Primary | 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. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 8 |
|
|
|
| Primary | 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. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 8 |
|
|
|
| Primary | 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. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 8 |
|
|
|
| Secondary | Interleukin-6 (IL-6) Frequency | The inflammatory marker IL-6 in CSF was examined. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 8 |
|
|
|
| Secondary | Interleukin-7 (IL-7) Frequency | The inflammatory marker IL-7 in CSF was examined. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 8 |
|
|
|
| Secondary | Interleukin-8 (IL-8) Frequency | The inflammatory marker IL-8 in CSF was examined. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 8 |
|
|
|
| Secondary | Interleukin-9 (IL-9) Frequency | The inflammatory marker IL-9 in CSF was examined. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 8 |
|
|
|
| Secondary | Interleukin-10 (IL-10) Frequency | The inflammatory marker IL-10 in CSF was examined. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 8 |
|
|
|
| Secondary | Monocyte Chemoattractant Protein 1 (MCP-1) Frequency | Monocyte chemoattractant protein 1 inflammatory markers in CSF were examined. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 8 |
|
|
|
| Secondary | Macrophage Derived Protein 1 (MDC-1) Frequency | Macrophage derived protein 1 inflammatory markers in CSF were examined. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 8 |
|
|
|
| Secondary | Transforming Growth Factor Alpha (TGF-α) Frequency | Transforming growth factor alpha inflammatory markers in CSF were examined. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 8 |
|
|
|
| Secondary | Tumor Necrosis Factor Alpha (TNF-α) Frequency | Tumor necrosis factor alpha inflammatory markers in CSF were examined. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 8 |
|
|
|
| Secondary | Intercellular Adhesion Molecule 1 (ICAM-1) Frequency | Intercellular adhesion molecule 1 inflammatory markers in CSF were examined. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Month 8 |
|
|
|
| Secondary | Vascular Cell Adhesion Molecule 1 (VCAM-1) Frequency | Vascular cell adhesion molecule 1 inflammatory markers in CSF were examined. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Month 8 |
|
|
|
| Secondary | Matrix Metalloproteinase (MMP) Frequency | Matrix metalloproteinase inflammatory markers will be examined in CSF. | MMP was not analyzed because since developing the protocol for this study much has been learned about inflammatory cytokines and chemokines as AD preclinical biomarkers. The biological assay menu options for group analyses changed to include only those that have been shown to be related to disease state and likelihood of progression. The marker MMP was removed from the preplanned menu of inflammatory markers by the manufacturer and having MMP analyzed independently was cost prohibitive. | Posted | Baseline, Month 8 |
|
|
| Secondary | Tissue Inhibitor of Metalloproteinase (TIMP) Frequency | Tissue inhibitor of metalloproteinase inflammatory markers will be examined in CSF. | TIMP was not analyzed because since developing the protocol for this study much has been learned about inflammatory cytokines and chemokines as AD preclinical biomarkers. The biological assay menu options for group analyses changed to include only those that have been shown to be related to disease state and likelihood of progression. The marker TIMP was removed from the preplanned menu of inflammatory markers by the manufacturer and having TIMP analyzed independently was cost prohibitive. | Posted | Baseline, Month 8 |
|
|
| Secondary | 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. | This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 8 |
|
|
|
| Other Pre-specified | Change in Structural Magnetic Resonance Imaging and White Matter Hyperintensities | High-resolution anatomical images will be acquired using a 3D-Fast Spoiled Gradient Recalled Echo (FSPGR) Sequence. White Matter Hyperintensities (WMH) will be identified by a 3D T2 Fluid Attenuated Inversion Recovery (FLAIR) Fast Spin Echo sequence. The images will be co-registered using a within-subject inter-modal alignment between structural and perfusion images. T1-weighted Spoiled Gradient Recalled (SPGR) images will be used to identify cerebrospinal fluid and white and gray matter. Increased volumes of white matter hyperintensities indicate impaired cognitive function. | Not Posted | Baseline, Month 8 | Participants |
| Other Pre-specified | Change in Arterial Spin Labeling-Magnetic Resonance Imaging | Echoplanar T1 mapping scans will be used for image registration and a scout image of the head will be obtained in order to choose the appropriate location for spin labeling and flow imaging. Arterial Spin Labeling images will be acquired using a custom 3D stack of interleaved spirals fast spin echo sequences and will be averaged in order to improve the signal-to-noise ratio. Images will be interpolated and smoothed in a panel by using a 0.5-pixel, full-width, half-maximum Gaussian kernel. Regional perfusion will be quantified in each hemisphere and maps of cerebral vasoreactivity will be obtained by co-registration of perfusion and anatomical images. | Not Posted | Baseline, Month 8 | Participants |
| 0 |
| 19 |
| 0 |
| 19 |
| 13 |
| 19 |
| EG001 | Telmisartan 40mg | African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. | 0 | 18 | 0 | 18 | 13 | 18 |
| EG002 | Placebo | African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. | 0 | 24 | 0 | 24 | 15 | 24 |
| Excessive swelling | General disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Postural hypotension | Cardiac disorders | Systematic Assessment |
|
| Persistent cough | General disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Systematic Assessment |
|
| Angioedema | Cardiac disorders | Systematic Assessment |
|
| Nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Syncope | General disorders | Systematic Assessment |
|
| Vertigo | General disorders | Systematic Assessment |
|
| Abnormal kidney function | Renal and urinary disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Unusual muscle aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Sore throat | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Dry mouth | General disorders | Non-systematic Assessment |
|
| Night sweats | General disorders | Non-systematic Assessment |
|
| Out of range labs | General disorders | Non-systematic Assessment |
|
| Cold symptoms | Infections and infestations | Non-systematic Assessment |
|
| Increased body temperature | General disorders | Non-systematic Assessment |
|
| Acid reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
| Trouble falling asleep | General disorders | Non-systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Difficulty swallowing | General disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Heart palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Low energy | General disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Weight loss | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Month 8 |
|
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| Month 8 |
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| Month 8 |
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| Month 8 |
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| Month 8 |
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| Month 8 |
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| Month 8 |
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| Month 8 |
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