A Pilot of the Feasibility of Using the Iron-Chelator Deferiprone on Mild Cognitive Impairment
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|ClinicalTrials.gov Identifier: NCT02878538|
Recruitment Status : Withdrawn (Study was withdrawn before IRB approval)
First Posted : August 25, 2016
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Drug: Deferiprone Other: Placebo phase||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||An N of One Clinical Trial to Pilot the Feasibility of Using the Iron-Chelator Deferiprone on Mild Cognitive Impairment|
|Estimated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2023|
Active Comparator: deferiprone
Deferiprone will be administered three times a day (25mg/kg). Total dose per day will depend on participants' body weight for one, three month block.
Subjects will then begin an experimental No1 design: placebo-deferiprone-placebo. Study drug will be administered in three 3 month blocks. All subjects will receive 30 days of active study drug. The placebo-deferiprone contrast compares placebo to active drug initiation. The deferiprone-placebo contrast tests active drug withdrawal. All will be given placebo in months 1-3, and 6-12. This will allow the investigators to examine active drug exposure on d score up to one year and prospective time to MCI conversion. Dosing: Participants will be treated 25 mg/kg po tid (75mg /kg /d total) The dose will be rounded by the prescriber to the nearest 250 mg (half-tablet).
Other Name: Ferriprox, ATC Code V03AC02
Placebo Comparator: Placebo Phase
Placebo tablets with inactive substance will be used. Total number of placebo tablets will be equivalent to the active tablets administered depending on participants' body weight for two, three month blocks.
Other: Placebo phase
Placebo tablets with inactive substance will be provided to subjects for two, 3 month blocks during the study.
- Efficacy of deferiprone therapy on "d" scores in Mild Cognitive Impairment (MCI) [ Time Frame: 12 months ]Using N of 1 trial design in small number of MCI cases to compare within subject response to placebo and deferiprone in a A1-A-A1 design
- Explore deferiprone's longitudinal effect on "d" and dementia conversion [ Time Frame: 12 months ]We want to survey the effect of deferiprone on "d" to see If serum biomarkers trigger dementing processes in non Hispanic whites and if deferiprone exposure in MCI may terminate progression and conversion to dementia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878538
|United States, Texas|
|University of Texas Health Science Center|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Donald R Royall, MD||The University of Texas Health Science Center at San Antonio|
|Principal Investigator:||Dean Kellogg, MD, PHD||The University of Texas Health Science Center at San Antonio|