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Trial record 1 of 1 for:    Pilot Trial of Carvedilol in Alzheimer’s Disease
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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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

Placebo

Non active substance

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


Participant Flow:   Overall Study
    Carvedilol   Placebo
STARTED   14   15 
COMPLETED   6   11 
NOT COMPLETED   8   4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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

Placebo

Non active substance

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

Total Total of all reporting groups

Baseline Measures
   Carvedilol   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   15   29 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      10  71.4%      6  40.0%      16  55.2% 
Male      4  28.6%      9  60.0%      13  44.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   Hopkins Verbal Learning Test (HVLT) Scores at Baseline, 3, and 6 Months   [ Time Frame: Baseline, 3 months, and 6 months ]

2.  Secondary:   Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers   [ Time Frame: 6 months ]

3.  Secondary:   Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Paul Rosenberg, MD
Organization: Johns Hopkins University
phone: 410-550-9883
e-mail: prosenb9@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01354444     History of Changes
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