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NCT01300728 · ClinicalTrials.gov registry record · Phase 2
Study of Intravenous Immunoglobulin in Amnestic Mild Cognitive Impairment
A Phase 2 study, sponsored by Sutter Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT01300728: Completed Phase 2 study, sponsored by Sutter Health.
NCT01300728 is a Phase 2 study that has completed, run by Sutter Health. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01300728, a Phase 2 study, has completed, sponsored by Sutter Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
Patients with mild cognitive impairment (MCI) are a group recognized at being at high risk of progressing to Alzheimer disease. Treatment of MCI with immunotherapy with intravenous immunoglobulins (IVIG) could potentially reduce the risk of progression to Alzheimer disease. This study will evaluate the efficacy of intravenous immunoglobulin in patients with MCI over 24 months after the first infusion. This study will also document conversion from MCI to Alzheimer's Disease.
Primary Outcome
Change in ventricular volumetric as measured by MRI at baseline, 12, and 24 months following the first infusion of either 0.4 g/kg NewGam or 0.9% saline solution(placebo) every 14 days x 5. Participants will also be classified as early MCI (EMCI) if baseline CDR-SB is less than 1.5, and late MCI (LMCI) if CDR-SB is greater than or equal to 1.5.
Interventions
- OTHER Placebo
- DRUG NewGam 10% IVIG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2011-01-01 |
| Est. Completion | 2020-03-12 |
| Phase | Phase 2 |
What the finished NCT01300728 record still lists
NCT01300728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01300728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01300728 about?
NCT01300728 is a clinical study titled "Study of Intravenous Immunoglobulin in Amnestic Mild Cognitive Impairment". Patients with mild cognitive impairment (MCI) are a group recognized at being at high risk of progressing to Alzheimer disease. Treatment of MCI with immunotherapy with intravenous immunoglobulins (IVIG) could potentially reduce the risk of progression to Alzheimer disease. This study will evaluate...
What is the current status of trial NCT01300728?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2011-01-01. Estimated completion is 2020-03-12.
What interventions are being tested in trial NCT01300728?
The interventions under investigation include: Placebo (OTHER), NewGam 10% IVIG (DRUG).
Who is sponsoring clinical trial NCT01300728?
This trial is sponsored by Sutter Health, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01300728's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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