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3-month Study of MSDC-0160 Effects on Brain Glucose Utilization, Cognition & Safety in Subjects With Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Metabolic Solutions Development Company
ClinicalTrials.gov Identifier:
NCT01374438
First received: June 14, 2011
Last updated: November 5, 2014
Last verified: November 2014
Results First Received: September 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: MSDC-0160
Drug: Placebo

  Participant Flow
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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
MSDC-0160 Capsules

MSDC tablets contained in #00 capsules

MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days

Placebo Capsules

Placebo tablets contained in #00 capsules

Placebo: Placebo capsules given once daily for 90 days


Participant Flow:   Overall Study
    MSDC-0160 Capsules     Placebo Capsules  
STARTED     16     13  
COMPLETED     16     13  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
All randomized subjects completed the full study and are included in the analysis.

Reporting Groups
  Description
MSDC-0160 Capsules

MSDC tablets contained in #00 capsules

MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days

Placebo Capsules

Placebo tablets contained in #00 capsules

Placebo: Placebo capsules given once daily for 90 days

Total Total of all reporting groups

Baseline Measures
    MSDC-0160 Capsules     Placebo Capsules     Total  
Number of Participants  
[units: participants]
  16     13     29  
Age  
[units: years]
Mean ± Standard Deviation
  72.3  ± 8.8     71.0  ± 8.0     71.7  ± 8.3  
Gender  
[units: participants]
     
Female     8     8     16  
Male     8     5     13  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     2     4  
White     14     11     25  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Presence of an Apolipoprotein E e4 allele  
[units: participants]
     
Apo E e4 allele present     10     9     19  
Apo E e4 allelle absent     6     4     10  
Mini-Mental State Examination Score [1]
[units: units on a scale]
Mean ± Standard Deviation
  22.8  ± 2.4     25.2  ± 2.1     23.9  ± 2.6  
[1] Screening Mini-Mental State Examination Score, Mean (SD). Possible scores range between 0 and 30. Scores ≥27 indicate normal cognition, 19-24 indicate mild impairment, 10-18 indicate moderate impairment, and scores ≤9 indicate severe impairment.



  Outcome Measures
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1.  Primary:   Effects of MSDC-0160 on Cerebral Metabolic Glucose Rate or Placebo Over 12 Weeks in Pre-specified Regions of Interest Analysis Referenced to Cerebellum   [ Time Frame: Days 1(baseline) and 91 ]

2.  Secondary:   Change From Baseline in Global Cognitive Function Tests   [ Time Frame: Days 1 (baseline) and 91 ]

3.  Secondary:   Change From Baseline in Cognitive Function as Determined by the ADAS-Cog Subscale   [ Time Frame: Days 1 (baseline) and 91 ]

4.  Secondary:   Change From Baseline in Cognitive Function as Estimate With the Executive Function Scale   [ Time Frame: Days 1 (baseline) and 91 ]

5.  Secondary:   Change From Baseline in HMW Adiponectin of MSDC-0160 or Placebo Over 12 Weeks   [ Time Frame: Days 1(baseline) and 91 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jerry Colca
Organization: Metabolic Solutions Development Company
phone: 269.343.8732
e-mail: jcolca@msdrx.com


No publications provided


Responsible Party: Metabolic Solutions Development Company
ClinicalTrials.gov Identifier: NCT01374438     History of Changes
Other Study ID Numbers: MSDC-0160-C006
Study First Received: June 14, 2011
Results First Received: September 25, 2014
Last Updated: November 5, 2014
Health Authority: United States: Food and Drug Administration