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A Non-drug Methods Study in Participants With Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01459016
First received: October 12, 2011
Last updated: December 21, 2016
Last verified: December 2016
Results First Received: December 21, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Alzheimer's Disease
Interventions: Other: PET scan using florbetapir
Other: MRI Scan

  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
Standard of Care Participants with prodromal to mild Alzheimer’s Disease (AD) underwent a florbetapir F 18 positron emission tomography (PET) scan. (Single intravenous microdose of 260 to 370 megabecquerels (MBq) [7 to 10 millicuries (mCi)] of florbetapir.) Those who tested amyloid positive and met other entry criteria received standard of care for up to 12 months (mos). No therapeutic investigational drug intended to treat AD was administered.

Participant Flow:   Overall Study
    Standard of Care
STARTED   56 
COMPLETED   41 
NOT COMPLETED   15 
Withdrawal by Subject                11 
Amendment Discontinuation Criteria                4 



  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 participants who enrolled in the study.

Reporting Groups
  Description
Standard of Care Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.

Baseline Measures
   Standard of Care 
Overall Participants Analyzed 
[Units: Participants]
 56 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.2  (7.7) 
Gender 
[Units: Participants]
Count of Participants
 
Female      22  39.3% 
Male      34  60.7% 
Region of Enrollment 
[Units: Participants]
 
France   56 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI)   [ Time Frame: Baseline, 6 Mos; Baseline, 12 Mos ]

2.  Primary:   Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Hippocampus Volume Average Percent (%) Change (Chg)   [ Time Frame: Baseline, 6 Mos; Baseline, 12 Mos ]

3.  Primary:   Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)   [ Time Frame: Baseline, 6 Mos; Baseline, 12 Mos ]

4.  Primary:   Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)   [ Time Frame: Baseline, 6 Mos; Baseline, 12 Mos ]

5.  Primary:   Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)   [ Time Frame: Baseline, 6 Mos; Baseline, 12 Mos ]

6.  Secondary:   Baseline Brain Amyloid Load Using Positron Emission Tomography (PET) and Florbetapir   [ Time Frame: Baseline ]

7.  Secondary:   Number of Participants With Vasogenic Edema on MRI Scan at a Field Strength of 3 Tesla (3T)   [ Time Frame: Baseline ]

8.  Secondary:   Number of Participants With Microhemorrhage on MRI Scan at a Field Strength of 3T   [ Time Frame: Baseline, 6 Mos; Baseline, 12 Mos ]

9.  Secondary:   Change From Baseline in the Mini Mental State Examination (MMSE) Total Score   [ Time Frame: Baseline, 6 Mos; Baseline, 12 Mos ]

10.  Secondary:   Change From Baseline in the Alzheimer’s Disease Assessment Scale Extended Cognitive Subscale (ADAS-Cog14) Total Score   [ Time Frame: Baseline, 6 Mos; Baseline, 12 Mos ]

11.  Secondary:   Change From Baseline in the Clinical Dementia Rating (CDR) Total Score   [ Time Frame: Baseline, 6 Mos; Baseline, 12 Mos ]


  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 less than or equal to 60 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: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01459016     History of Changes
Other Study ID Numbers: 14162
I4O-MC-BACH ( Other Identifier: Eli Lilly and Company )
Study First Received: October 12, 2011
Results First Received: December 21, 2016
Last Updated: December 21, 2016