A Non-drug Methods Study in Participants With Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT01459016 |
Recruitment Status
:
Completed
First Posted
: October 25, 2011
Results First Posted
: February 13, 2017
Last Update Posted
: February 13, 2017
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
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Tracking Information | ||||
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First Submitted Date ICMJE | October 12, 2011 | |||
First Posted Date ICMJE | October 25, 2011 | |||
Results First Submitted Date | December 21, 2016 | |||
Results First Posted Date | February 13, 2017 | |||
Last Update Posted Date | February 13, 2017 | |||
Study Start Date ICMJE | December 2011 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT01459016 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Non-drug Methods Study in Participants With Alzheimer's Disease | |||
Official Title ICMJE | An Exploratory Study of Brain Imaging Biomarkers in Patients With Alzheimer's Pathology Receiving Standard of Care | |||
Brief Summary | This study will investigate the volume, function and composition of the brain using magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning technology in participants with memory complaints or early signs of Alzheimer's pathology. | |||
Detailed Description | After trial initiation, the protocol was amended to extend the single observation time period (6 to 9 months) to two time points (6 and 12 months), and to focus on prodromal AD (Mini-Mental State Examination [MMSE] 23-30 inclusive, Free and Cued Selective Reminding Test [FCSRT] less than or equal to [≤] 24 for free recall or ≤ 44 for total recall). Participants enrolled under the original protocol were allowed to continue in the extension study if they so desired, and if they met the new inclusion criteria. Due to the number of participants that completed the extended trial, no sub-group analysis was performed based on which amendment the participants entered under. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Alzheimer's Disease | |||
Intervention ICMJE |
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Study Arms | Experimental: Imaging Biomarkers
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
56 | |||
Original Estimated Enrollment ICMJE |
196 | |||
Actual Study Completion Date | December 2014 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 55 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01459016 | |||
Other Study ID Numbers ICMJE | 14162 I4O-MC-BACH ( Other Identifier: Eli Lilly and Company ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Eli Lilly and Company | |||
Study Sponsor ICMJE | Eli Lilly and Company | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Eli Lilly and Company | |||
Verification Date | December 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |