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SEAIRA

CompletedPhase 4Results posted

Studying the Effects of Antihypertensives on Individuals at Risk for Alzheimer's

Asset

Ramipril

Listed sites

1

Recruiting sites

-

Enrollment

14

actual

Study population

Alzheimer’s disease

Key I/E criterion

Age 40-65

Primary endpoint

Cerebrospinal Fluid (CSF) Amyloid Beta-42 (Aβ42) Levels Between Baseline

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

Org study ID2014-1353
Secondary IDH-2009-0036UW Madison IRB
NCT IDNCT00980785
Secondary IDSMPH/MEDICINE/GER-AD DEVUW, Madison

Timeline

Milestones

Study start2009-04-09actual
Study first posted2009-09-21estimated
Primary completion2011-07-26actual
Study completion2011-07-26actual
Last update posted2020-08-25actual
Results first posted2020-08-25actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Between the ages of 40 and 65
Mean resting blood pressure between 130-160 systolic and 85-100 diastolic
Parent with Alzheimer's Disease

Exclusion criteria

Current involvement in another investigational drug trial.
Potassium > 5.0
Dementia based on DSMIV criteria
Mini-Mental State Exam (MMSE) score < 27
Current blood pressure medication (< 4 months from screening)
Weight loss medication
Contraindications for LP
Know diagnosis or history of hospitalization due to congestive heart failure
Elevated creatinine (females > 1.3 mg/dL or males > 1.4 mg/dL at baseline)
Diabetes Type I and II
Know adverse reaction to an ACE-I or an angiotensin receptor blocker
Pregnant of nursing women

Endpoints (8)

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

Other (unclassified)
4
Global cognition
2
Amyloid biomarkers
2

Global cognition

2 endpoints
Secondary/protocol endpoint

Change in CSF Angiotensin Converting Enzyme (ACE) Levels Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo

Time frame:Baseline to 4 months

change from baseline, improvement

Secondary/registry result

Change in CSF Angiotensin Converting Enzyme (ACE) Levels Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo

Time frame:Baseline to 4 months

change from baseline, improvement

Posted result

GroupValue (mean), U/LStandard deviation
Placebon=6 Participants-0.100.21
Activen=8 Participants-0.630.32
Mean Difference (Final Values)-0.10p0.009Wilcoxon (Mann-Whitney)
Mean Difference (Final Values)-0.63p0.009Wilcoxon (Mann-Whitney)

Amyloid biomarkers

2 endpoints
Primary/protocol endpoint

Change in Cerebrospinal Fluid (CSF) Amyloid Beta-42 (Aβ42) Levels Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo

Time frame:Baseline to 4 months

change from baseline, improvement

Primary/registry result

Change in Cerebrospinal Fluid (CSF) Amyloid Beta-42 (Aβ42) Levels Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo

Time frame:Baseline to 4 months

change from baseline, improvement

Posted result

GroupValue (mean), pg/mlStandard deviation
Placebon=6 Participants-22.578.7
Activen=8 Participants-31.7190.6
Mean Difference (Final Values)-22.5p0.836Wilcoxon (Mann-Whitney)
Mean Difference (Final Values)-31.71p0.836Wilcoxon (Mann-Whitney)

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

Change in Flow-mediated Vasodilation (FMD) Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo

Time frame:Baseline to 4 months

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Augmentation Index (%) Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo

Time frame:Baseline to 4 months

change from baseline, improvement

Secondary/registry result/low confidence

Change in Flow-mediated Vasodilation (FMD) Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo

Time frame:Baseline to 4 months

percent change from baseline, improvement

Posted result

GroupValue (mean), Percentage changeStandard deviation
Placebon=6 Participants-0.701.56
Activen=8 Participants-0.291.23
Mean Difference (Final Values)-0.70p0.755Wilcoxon (Mann-Whitney)
Mean Difference (Final Values)-0.29p0.755Wilcoxon (Mann-Whitney)
Secondary/registry result/low confidence

Change in Augmentation Index (%) Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo

Time frame:Baseline to 4 months

change from baseline, improvement

Posted result

GroupValue (mean), Percentage changeStandard deviation
Placebon=6 Participants1.78.9
Activen=8 Participants-1.82.2
Mean Difference (Final Values)1.7p0.491Wilcoxon (Mann-Whitney)
Mean Difference (Final Values)-1.8p0.491Wilcoxon (Mann-Whitney)

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.

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.