Alzheimer's Disease Education and Referral Center

Carvedilol in Alzheimer's Disease

Carvedilol in Alzheimer's Disease

Overall Status: 
Recruiting
Brief Description: 

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.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
N/A
N/A
Both
No
Inclusion Criteria: 

  • 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

Exclusion Criteria: 

  • 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

Detailed Description: 

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.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 39.2713976, -76.5603828

Johns Hopkins School of Medicine Bayview Campus
Baltimore
Maryland
21224
Recruiting
Julia Pedroso
410-550-9054
jpedroso@jhmi.edu
Lead Sponsor: 
Agency
Johns Hopkins University
Collaborator Sponsor: 
Agency
Mount Sinai School of Medicine
Facility Investigators: 
NameRoleAffiliation
Paul B. Rosenberg, MD
Principal Investigator
Johns Hopkins University
Study Contact: 
NamePhoneEmail
Paul B. Rosenberg, MD
410-550-9883
Julia Pedroso
410-550-9054
Locations
 
 
ClinicalTrials.gov ID 
NCT01354444 (follow link to view full record on ct.gov in new window)
Official Title: 
Pilot Trial of Carvedilol in Alzheimer's Disease
Study Start Date: 
June 2011
Study End Date: 
June 2015
Disease Stage: 
Early
Enrollment: 
50