Studying the Effects of Antihypertensives on Individuals at Risk for Alzheimer's (SEAIRA)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease Hypertension |
Drug: Ramipril Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Studying the Effects of Antihypertensives on Individuals at Risk for Alzheimer's |
- To determine the effects of 4 months of ramipril therapy on CSF Aβ levels in mildly hypertensive, non-demented adult children of persons with AD when compared to subjects taking placebo. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- To evaluate the effects of 4 months of ramipril on CSF ACE levels in mildly hypertensive, non-demented adult children of persons with AD when compared to subjects taking placebo. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- To determine the effects of 4 months of ramipril therapy on the cardiovascular outcome variables of brachial reactivity and aortic augmentation index in non-demented adult children of persons with AD when compared to subjects taking placebo. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Enrollment: | 14 |
| Study Start Date: | April 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Matching Placebo
|
Drug: Placebo
Matching Placebo
|
|
Experimental: Active
Ramipril 5mg/day
|
Drug: Ramipril
Ramipril 5 mg/day
Other Name: Altace
|
Detailed Description:
High blood pressure (BP) in midlife is predictive of Alzheimer's disease (AD) in later life. Similarly, reductions in BP are associated with protection against AD. Treatment with antihypertensive medications, specifically angiotensin converting enzyme inhibitors (ACE-I) such as ramipril, is associated with up to a 55% reduction in the prevalence of AD, suggesting a potentially promising role for ACE-I in the prevention of AD. It is unknown however 1) whether ACE-Is will have the same effect on CSF Aβ levels in humans as in animal models 2) whether ACE-Is induce changes associated with vascular function (i.e. levels of CSF angiotensin converting enzyme (ACE) and peripheral endothelial function) and 3) whether there are interactions between ACE-I-induced changes in CSF Aβ, CSF ACE and indices of vascular function.
One mechanism by which antihypertensives may protect against AD is via Aβ neuropathology. In order to better understand the mechanisms through which ACE-I may modify CSF Aβ and possibly AD risk, we propose a randomized, double-blind, placebo-controlled pilot clinical trial, enrolling 20 middle-aged (age range 40 - 65 years), mildly hypertensive (between 130 - 160 mmHg mean systolic and between 85 - 100 mmHg mean diastolic) participants, who are adult children of an individual with AD. The main objective of this trial is to examine the effects of the ACE-I, ramipril, on 1) CSF Aβ levels 2) CSF ACE levels and 3) peripheral endothelial function as measured by brachial artery flow-mediated vasodilation (FMD) and aortic augmentation index (AAIx), in middle-aged adults with mildly elevated BP, who are at increased risk of developing AD.
Eligibility| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
- MMSE < 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00980785 History of Changes |
| Other Study ID Numbers: | H-2009-0036 |
| Study First Received: | September 18, 2009 |
| Last Updated: | July 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Wisconsin, Madison:
|
Alzheimer's Disease Hypertension |
Additional relevant MeSH terms:
|
Alzheimer Disease Hypertension Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Vascular Diseases |
Cardiovascular Diseases Antihypertensive Agents Ramipril Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 13, 2013