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 Age | Max Age | Gender | Healthy 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 | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 39.2713976, -76.5603828 | Johns Hopkins School of Medicine, Bayview Campus | Baltimore | Maryland | 21224 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Johns Hopkins University |
Collaborator Sponsor:
| Agency |
|---|
Mount Sinai School of Medicine |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Paul B. Rosenberg, MD | Principal Investigator | Johns Hopkins University |
Study Contact:
| Name | Phone | |
|---|---|---|
Paul B. Rosenberg, MD | 410-550-9883 |
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:
April 2014
Disease Stage:
Early
Enrollment:
50
