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

NCT00980785 | Completed Phase 4 Results DMC FDA Drug

• 4 other identifiers: 2014-1353H-2009-0036A534255SMPH/MEDICINE/GER-AD DEV
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease; Hypertension

Keywords

Alzheimer's Disease; Hypertension

Outcome Measures

Primary Outcomes (1)

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

  CSF Aβ42 levels will be measured from the cerebrospinal fluid taken from subjects on ramipril or placebo at the baseline visit and month 4 and will be measured by Dr. Henrik Zetterberg's laboratory.

  Baseline to 4 months

Secondary Outcomes (3)

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

  Baseline to 4 months

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

  Baseline to 4 months

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

  Baseline to 4 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Active

EXPERIMENTAL

Ramipril 5mg/day

Drug: Ramipril

Interventions

Ramipril DRUG

Ramipril 5 mg/day

Also known as: Altace

Active

Placebo DRUG

Matching Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Wisconisn Alzheimer's Disease Research Center

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• Wharton W, Stein JH, Korcarz C, Sachs J, Olson SR, Zetterberg H, Dowling M, Ye S, Gleason CE, Underbakke G, Jacobson LE, Johnson SC, Sager MA, Asthana S, Carlsson CM. The effects of ramipril in individuals at risk for Alzheimer's disease: results of a pilot clinical trial. J Alzheimers Dis. 2012;32(1):147-56. doi: 10.3233/JAD-2012-120763.

  PMID: 22776970 BACKGROUND

Related Links

• Related Info
• The Effects of Ramipril in Individuals at Risk for Alzheimer's Disease: Results of a Pilot Clinical Trial

MeSH Terms

Conditions

Alzheimer Disease; Hypertension

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Limitations included small sample size, short duration of trial, and lack of A-beta neuropathology.

Results Point of Contact

• Title: Cynthia M. Carlsson, MD, MS
• Organization: University of Wisconsin School of Medicine and Public Health

cmc@medicine.wisc.edu

608-256-1901

Study Officials

• Cynthia M Carlsson, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 21, 2009
• Study Start: April 9, 2009
• Primary Completion: July 26, 2011
• Study Completion: July 26, 2011
• Last Updated: August 25, 2020
• Results First Posted: August 25, 2020

Record last verified: 2020-08

Locations

US (1)