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Trial of Carvedilol in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT01354444
Recruitment Status : Completed
First Posted : May 16, 2011
Results First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: Carvedilol
Drug: Placebo
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carvedilol Placebo
Hide Arm/Group Description

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.

Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice

Non active substance

Placebo: a pill that will look like the active drug but will not contain any carvedilol

Period Title: Overall Study
Started 14 15
Completed 6 11
Not Completed 8 4
Arm/Group Title Carvedilol Placebo Total
Hide Arm/Group Description

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.

Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice

Non active substance

Placebo: a pill that will look like the active drug but will not contain any carvedilol

Total of all reporting groups
Overall Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  35.7%
6
  40.0%
11
  37.9%
>=65 years
9
  64.3%
9
  60.0%
18
  62.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
Female
10
  71.4%
6
  40.0%
16
  55.2%
Male
4
  28.6%
9
  60.0%
13
  44.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  21.4%
1
   6.7%
4
  13.8%
White
11
  78.6%
14
  93.3%
25
  86.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Hopkins Verbal Learning Test (HVLT) Scores at Baseline, 3, and 6 Months
Hide Description The investigators measured 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. Changes in HVLT Immediate and Delayed Recall score in 14 Alzheimer's Disease (AD) participants taking carvedilol vs. 15 AD participants taking placebo were compared. HVLT test score ranges are as follows: immediate recall (0-24) delayed recall (0-12). Higher scores indicate better episodic memory recall.
Time Frame Baseline, 3 months, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HVLT Score in Placebo Group HVLT Score in Treatment Group
Hide Arm/Group Description:
Descriptive statistics for immediate recall in the Hopkins Verbal Learning Test in the placebo group
Descriptive statistics for immediate recall in the Hopkins Verbal Learning Test in the treatment group
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
HVLT score at Baseline (immediate recall) 13  (4) 12  (6)
HVLT score at 3 months (immediate recall) 12  (5) 13  (4)
HVLT score at 6 months (immediate recall) 12  (5) 13  (6)
HVLT score at Baseline (delayed recall) 1  (2) 1  (1)
HVLT score at 3 months (delayed recall) 1  (2) 1  (2)
HVLT score at 6 months (delayed recall) 1  (2) 0  (0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HVLT Score in Placebo Group, HVLT Score in Treatment Group
Comments This analysis compares immediate recall before and after 6 months between the treatment and placebo group.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.565
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Coefficient
Estimated Value 1.48
Confidence Interval (2-Sided) 95%
-3.796 to 6.761
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers
Hide Description 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 6 AD participants taking carvedilol vs. 10 AD participants taking placebo. These 16 participants had both baseline and 6 month CSF collected (of the entire study population). CSF was collected at the baseline visit and 6 months later.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carvedilol Placebo
Hide Arm/Group Description:

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.

Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice

Non active substance

Placebo: a pill that will look like the active drug but will not contain any carvedilol

Overall Number of Participants Analyzed 6 10
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline Tau (pg/mL) 169.476  (93.931) 169.484  (48.386)
Baseline ABeta42 (pg/mL) 396.985  (212.411) 379.406  (100.892)
Baseline P tau (pg/mL) 42.666  (10.176) 66.133  (24.503)
Six month Tau (pg/mL) 222.461  (139.839) 171.757  (53.72)
Six month ABeta42 (pg/mL) 499.325  (174.308) 361.563  (89.044)
Six month P tau (pg/mL) 56.003  (23.984) 64.331  (25.766)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Carvedilol, Placebo
Comments This analysis compares the change in total Tau between the treatment and placebo group from baseline to 6 months later.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.481
Comments [Not Specified]
Method Rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Carvedilol, Placebo
Comments This analysis compares the change in Abeta42 between the treatment and placebo group from baseline to 6 months later.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0562
Comments [Not Specified]
Method Rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Carvedilol, Placebo
Comments This analysis compares the change in p-tau between the treatment and placebo group from baseline to 6 months later.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.314
Comments [Not Specified]
Method Rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Carvedilol, Placebo
Comments This analysis compares the change in oligomeric Abeta between the treatment and placebo group from baseline to 6 months later.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.438
Comments [Not Specified]
Method Rank sum test
Comments [Not Specified]
3.Secondary Outcome
Title Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers
Hide Description 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 6 AD participants taking carvedilol vs. 10 AD participants taking placebo. These 16 participants had both baseline and 6 month CSF collected (of the entire study population).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carvedilol Placebo
Hide Arm/Group Description:

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.

Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice

Non active substance

Placebo: a pill that will look like the active drug but will not contain any carvedilol

Overall Number of Participants Analyzed 6 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline Oligomeric ABeta (ng/mL) 3.83  (3.314) 0.129  (0.034)
Six month oligomeric ABeta (ng/mL) 3.895  (3.376) 0.117  (0.101)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events are presented without regard to the specific Adverse Event Term.
 
Arm/Group Title Carvedilol Placebo
Hide Arm/Group Description

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.

Carvedilol: target dose of 25 mg daily which is half the maximum dose used in clinical practice

Non active substance

Placebo: a pill that will look like the active drug but will not contain any carvedilol

All-Cause Mortality
Carvedilol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Carvedilol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/14 (14.29%)      1/15 (6.67%)    
Blood and lymphatic system disorders     
HEME  1/14 (7.14%)  1 0/15 (0.00%)  0
Gastrointestinal disorders     
GI  0/14 (0.00%)  0 1/15 (6.67%)  1
Nervous system disorders     
Neurologic  1/14 (7.14%)  1 0/15 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Carvedilol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/14 (85.71%)      12/15 (80.00%)    
Blood and lymphatic system disorders     
HEME  1/14 (7.14%)  1 1/15 (6.67%)  1
Cardiac disorders     
Cardiac  10/14 (71.43%)  10 10/15 (66.67%)  10
Gastrointestinal disorders     
GI  2/14 (14.29%)  2 3/15 (20.00%)  3
Immune system disorders     
Oncology  1/14 (7.14%)  1 0/15 (0.00%)  0
Infections and infestations     
Infectious disease  1/14 (7.14%)  1 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders     
Arthritis  0/14 (0.00%)  0 4/15 (26.67%)  4
Nervous system disorders     
Systemic  2/14 (14.29%)  2 4/15 (26.67%)  4
Neurologic  2/14 (14.29%)  2 2/15 (13.33%)  2
Psychiatric disorders     
Psychiatric  1/14 (7.14%)  1 5/15 (33.33%)  5
Skin and subcutaneous tissue disorders     
Dermatologic  0/14 (0.00%)  0 1/15 (6.67%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul Rosenberg, MD
Organization: Johns Hopkins University
Phone: 410-550-9883
EMail: prosenb9@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01354444    
Other Study ID Numbers: NA_00035546
First Submitted: May 9, 2011
First Posted: May 16, 2011
Results First Submitted: October 26, 2017
Results First Posted: February 6, 2018
Last Update Posted: February 6, 2018