Trial of Carvedilol in Alzheimer's Disease
This is a 6-month pilot randomized double-blind placebo-controlled trial of carvedilol, with the primary objective being to determine whether carvedilol treatment is associated with improvement in Alzheimer's Disease (AD) as compared to placebo treatment. Secondary objectives are to monitor changes in cerebrospinal fluid amyloid levels and whether this dose will be safe and well-tolerated in AD patients. 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Pilot Trial of Carvedilol in Alzheimer's Disease|
- To determine whether carvedilol treatment has a beneficial effect on episodic recall [ Time Frame: 6 months ] [ Designated as safety issue: No ]The investigators will measure episodic memory (as evidence by the Hopkins Verbal Learning Test [HVLT]) before and after 6 months randomized placebo-controlled double-blind treatment with carvedilol at a target dose of 25 mg daily, comparing changes in HVLT Immediate and Delayed Recall score in 25 AD participants taking carvedilol vs. 25 AD participants taking placebo.
- To determine whether carvedilol treatment is associated with decrease in CSF levels of amyloid-beta oligomers [ Time Frame: 6 months ] [ Designated as safety issue: No ]The investigators will measure CSF Abeta oligomer levels before and after 6 months randomized placebo-controlled double-blind treatment with carvedilol at a target dose of 25 mg daily, comparing the change in levels in 25 AD participants taking carvedilol vs. 25 AD participants taking placebo.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Carvedilol
Carvedilol is a is a beta-blocker. Beta-blockers are generally used to reduce the workload on the heart and help it to beat more regularly.
target dose of 25 mg daily which is half the maximum dose used in clinical practice
Placebo Comparator: Placebo
Non active substance
a pill that will look like the active drug but will not contain any carvedilol
The purpose of the study is measure decline in episodic memory, in participants taking carvedilol in early AD, when compared to placebo treatment. (as evidenced by the Hopkins Verbal Learning Test [HVLT]). cerebrospinal fluid levels of Aβ oligomers in early AD, will be measured in participants receiving carvedilol treatment when compared to placebo treatment. Adverse effects will be monitored in participants receiving carvedilol when compared to placebo.
To assess adverse events, routine chemistry and hematology studies, vital signs, and electrocardiographic parameters before and after 6 months randomized placebo-controlled double-blind treatment with carvedilol at a target dose of 25 mg daily, comparing 25 early AD participants taking carvedilol vs. 25 early AD participants taking placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354444
|Contact: Paul B Rosenberg, MDfirstname.lastname@example.org|
|Contact: Julia J. Pedroso, RN, MAemail@example.com|
|United States, Maryland|
|Johns Hopkins School of Medicine Bayview Campus||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Julia J. Pedroso, RN, MA 410-550-9054 firstname.lastname@example.org|
|Contact: Lynn Smith, MA 410-550-9053 email@example.com|
|Principal Investigator: Paul B Rosenberg, MD|
|Principal Investigator:||Paul B. Rosenberg, M.D.||Johns Hopkins University|