At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 58 enrolled
Drug / intervention
Placebo +1 moredrug
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.
Prospective 24-week, Double-blind, Randomised, Placebo-controlled, Multicenter Study Evaluating Safety and Change in Efficacy-related Surrogate Parameters in Patients With Dementia of the Alzheimer's Type Under Treatment With Increasing Dosages of Intravenous Immunoglobulin (Octagam 10%)
In Brief
A Phase 2 clinical trial evaluating Placebo and octagam 10% for Alzheimer's Disease. Completed, enrolled 58 participants across 1 site.
Detailed Summary
This study evaluated the effect of 6 or 12 infusions of different doses of octagam (intravenous immunoglobulin \[IVIG\]) 10% on the reduction of amyloid beta peptide (Aβ) in cerebral spinal fluid (CSF) and on the increase of Aβ in blood plasma in patients with mild to moderate Alzheimer's disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2008
Enrollment StartFeb 2009
Primary CompletionSep 2010
TodayJul 2026
First PostedDec 22, 2008
Enrollment StartFeb 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.5 years ago
Interventions
Placebodrug
Commercially available 0.9% isotonic sodium chloride solution.
octagam 10%biological
octagam 10% was supplied as ready-to-use solutions of human immunoglobulin.