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NCT00299988 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Intravenous Immunoglobulin (IVIg) for Alzheimer's Disease
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00299988: Clinical Trial Phase 2 study, sponsored by Weill Medical College of Cornell University.
NCT00299988 is a Phase 2 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00299988, a Phase 2 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
The overall goal of this double-blind Phase II study is to evaluate the safety, efficacy and biological mechanisms of action of Intravenous Immunoglobulin (IVIg) in the treatment of mild to moderate stage Alzheimer's disease (AD). IVIg contains antibodies against the amyloid beta protein that is the central component of the AD senile plaque. It is hypothesized that IVIg treatment will reduce the levels of beta amyloid in the brain and improve cognitive abilities relative to placebo. A total of 24 patients with mild to moderate AD capable of giving informed consent will be randomly assigned to receive either IVIg (16 patients)or saline placebo (8 patients) for six months. This study includes comparison of four dosing regimens of IVIg. Cognitive, behavioral and functional measures will be collected at baseline, three months and six months of treatment. Plasma samples will be collected before and after infusions. Subjects will undergo a lumbar puncture before and after the six months of treatment for cerebrospinal fluid (CSF) biomarker analyses. In addition, Positron Emission Tomography (PET) imaging substudies will be performed at two time points during the study. Following the initial 6 month placebo-controlled period, all participants have the opportunity to receive IVIg for an additional 12 month period in an extension study.
Primary Outcome
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia. It is one of the most widely used cognitive scales in clinical trials and is considered to be the "gold standard" for assessing antidementia treatments. The ADAS-Cog range from 0 to 70, where higher scores indicate greater cognitive dysfunction.
Interventions
- OTHER Placebo
- DRUG Intravenous Immunoglobulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2006-02 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
Why NCT00299988 stopped before completion
NCT00299988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00299988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00299988 about?
NCT00299988 is a clinical study titled "Phase II Study of Intravenous Immunoglobulin (IVIg) for Alzheimer's Disease". The overall goal of this double-blind Phase II study is to evaluate the safety, efficacy and biological mechanisms of action of Intravenous Immunoglobulin (IVIg) in the treatment of mild to moderate stage Alzheimer's disease (AD). IVIg contains antibodies against the amyloid beta protein that is the...
What is the current status of trial NCT00299988?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2006-02. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00299988?
The interventions under investigation include: Placebo (OTHER), Intravenous Immunoglobulin (DRUG).
Who is sponsoring clinical trial NCT00299988?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00299988's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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