Carvedilol in Alzheimer's Disease
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|
++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.
Johns Hopkins School of Medicine Bayview Campus
Pilot Trial of Carvedilol in Alzheimer's Disease