At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 5 enrolled
Drug / intervention
Octagam 10%biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Proof of Concept of the Effect of Intravenous Immunoglobulin on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer Disease
In Brief
A Phase 2 clinical trial evaluating Octagam 10% for Mild Cognitive Impairment. Completed, enrolled 5 participants across 1 site.
Detailed Summary
This is a proof of concept study to determine if changes in brain amyloid levels are evident three months after infusion of 0.4 g/kg of IVIG every 14 days x 5 infusions. Amyloid levels will be measured by Florbetapir PET and retinal scan.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild Cognitive Impairment
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartJan 2018
Primary CompletionJul 2018
TodayJul 2026
First PostedOct 24, 2017
Enrollment StartJan 4, 2018
Primary CompletionJul 19, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.7 years ago
Interventions
Octagam 10%biological
FDA approved human normal immunoglobulin solution ready for intravenous administration