Phase 4
N=14
Studying the Effects of Antihypertensives on Individuals at Risk for Alzheimer's
Alzheimer's Disease · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00980785 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Change in Cerebrospinal Fluid (CSF) Amyloid Beta-42 (Aβ42) Levels Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo — -22.5; -31.71 pg/ml — p=0.836
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ramipril (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cerebrospinal Fluid (CSF) Amyloid Beta-42 (Aβ42) Levels Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo |
-22.5; -31.71 | 0.836 |
| SECONDARY Change in CSF Angiotensin Converting Enzyme (ACE) Levels Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo |
-0.10; -0.63 | 0.009 sig |
| SECONDARY Change in Flow-mediated Vasodilation (FMD) Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo |
-0.70; -0.29 | 0.755 |
| SECONDARY Change in Augmentation Index (%) Between Baseline and Month 4 in Subjects Taking Ramipril vs Subjects on Placebo |
1.7; -1.8 | 0.491 |
Summary
Angiotensin converting enzyme inhibitors (ACE-I) are a group of blood pressure-lowering medicines. Some studies suggest that ACE-I, such as ramipril, may help prevent Alzheimer's disease (AD). The purpose of the research is to see how ramipril affects a substance in the body called beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the brain and spinal cord. High amounts of beta-amyloid may be associated with a greater risk of getting Alzheimer's disease. This study will see if ramipril can lower the amount of beta-amyloid in the spinal fluid. This study will also see if ramipril affects blood vessel function and memory and thinking. The investigators hope that future studies will show whether ramipril might prevent memory loss and decrease the chance of developing Alzheimer's disease.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00980785). 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.