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Carvedilol in Alzheimer's Disease

Completed

The purpose of this study is to determine whether taking carvedilol, a beta-blocker used to treat heart failure and high blood pressure, is associated with improvement in Alzheimer's disease compared to a placebo.

Minimum Age Maximum Age Gender Healthy Volunteers
N/A N/A Both No
June 2011
December 2016
50

++Diagnosis of Alzheimer's disease by NINCDS/ADRDA criteria ++Mini-Mental State Exam (MMSE) score of 16-26; Clinical Dementia Rating (CDR) score of less than 1++May remain on current FDA-approved Alzheimer's treatments, including cholinesterase inhibitors and memantine, with stable dose for at least 3 months++May remain on antidepressant and antipsychotics medications with stable dose for at least 3 months++Knowledgeable family member or other caregiver available for all study visits

++Evidence of non-Alzheimer's dementias, including Huntington's disease, Parkinson's disease, or frontotemporal dementia++Current DSM-IV Axis I diagnoses other than dementia, including major depression, bipolar disorder, schizophrenia, anxiety disorders, alcohol abuse, or other substance abuse++Any clinically significant medical condition that could interfere with the participant's ability to safely participate in the study or to be followed++Current use of beta-blocking agents++Contraindications to use of beta-blocking agents++Clinically significant liver or kidney insufficiency

This 6-month pilot trial will measure the decline in episodic memory in 50 participants with early-stage AD. Half will take carvedilol, a beta-blocker drug used to treat heart failure and high blood pressure, and half will take a placebo. Secondary objectives are to monitor changes in cerebrospinal fluid amyloid levels and to determine whether a 25-mg dose of carvedilol is safe and well-tolerated in people with Alzheimer's disease. Clinical assessments will be performed at baseline, 3 months, and 6 months, while cerebrospinal fluid and blood samples will be obtained at baseline and 6 months. Adverse effects will be monitored.

Name City State Zip Status Primary Contact
Johns Hopkins School of Medicine Bayview Campus
Baltimore Maryland 21224

Johns Hopkins University

  • Mount Sinai School of Medicine

Name Role Affiliation
Paul B. Rosenberg, MD Principal Investigator Johns Hopkins University

Name Phone Email
Paul B. Rosenberg, MD 410-550-9883 prosenb9@jhmi.edu
Julia Pedroso 410-550-9054 jpedroso@jhmi.edu

NCT01354444

Pilot Trial of Carvedilol in Alzheimer's Disease