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Candesartan's Effects on Alzheimer's Disease and Related Biomarkers

Recruiting

This Phase II study will investigate the effect of candesartan, a medication used to treat high blood pressure, on cognitive function in people with mild cognitive impairment (MCI), a condition of higher-than-normal memory and thinking difficulties for one's age.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years N/A All No
June 2016
September 2021
72

  • Mild cognitive impairment, as defined by:
    • Subjective memory concern
    • Abnormal memory function documented using the Logical Memory subscale from the Wechsler Memory Scale-Revised of less than 11 for 16 or more years of education, less than 9 for 8 to 15 years of education, and less than 6 for 7 of fewer years of education
    • Montreal Cognitive Assessment score less than 26
    • Clinical Dementia Rating scale/Memory Sum Box score of 0.5
    • General functional performance sufficiently preserved
  • Evidence for Alzheimer's disease, as shown by biomarkers
  • For participants who cannot understand the details of the study and/or cannot consent, study partners/surrogates who can sign on their behalf 

  • Intolerance to angiotensin II receptor blockers (ARBs)
  • Current diagnosis of hypertension or use of ARBs or other antihypertensive medication used for hypertensive therapy
  • Systolic blood pressure of less than 110 mm Hg or diastolic blood pressure of less than 40 mm Hg
  • Renal disease (creatinine level of >2.0 mg/dl), hyperkalemia (potassium level of >5.5 meq/dl), platelets <50,000/l, or INR >1.9
  • Active medical or psychiatric disease that would affect participant's safety or study's scientific integrity
  • Uncontrolled congestive heart failure, reflected by poor exercise tolerance and shortness of breath
  • History of stroke in the past 3 years
  • Inability to undergo magnetic resonance imaging (MRI), complete cognitive assessments, or have amyloid positivity assessed through lumbar puncture or amyloid scan; those who cannot undergo MRI (metal implants or cardiac pacemaker) may participate if all other parts of study are completed successfully
  • History of increased intracranial pressure or bleeding diathesis from disease states or from use of anticoagulants such as warfarin, heparin, and related products; rivaroxaban (Xarelto); apixaban (Eliquis); edoxaban (Savaysa); or dabigatran (Pradaxa)
  • Women of childbearing potential
  • Current use of lithium, as candesartan may increase lithium concentration to toxic levels

Participants will be randomly assigned to take either candesartan or a placebo for 1 year. All participants will start with 8 mg per day, to be increased in 2-week increments to 16 mg and 32 mg as long as systolic blood pressure remains above 110 mm Hg, diastolic blood pressure remains above 40 mm Hg, and participant reports no dizziness or weakness. The highest achievable dose will be given for the duration of the study.

The investigators will assess if blocking the effect of Ang II, a crucial mediator of neurovascular injury, using candesartan (an angiotensin II receptor antagonist, or ARB) will address shortcomings of current Alzheimer's treatments and how the drug affects blood-vessel stiffness and Alzheimer's-related biomarkers, including levels of amyloid and tau in cerebrospinal fluid.

Name City State Zip Status Primary Contact
Emory University
Atlanta Georgia 30322 Recruiting Ihab Hajjar, MD
404-712-7250
ihajjar@emory.edu
Wesley Woods Center
Atlanta Georgia 30329 Recruiting Ihab Hajjar, MD
404-712-7250
ihajjar@emory.edu

Emory University

Name Role Affiliation
Ihab Hajjar, MD Principal Investigator Emory University

Name Phone Email
Ihab Hajjar, MD 404-712-7250 ihabhajjar@emory.edu

NCT02646982

Candesartan's Effects on Alzheimer's Disease And Related Biomarkers