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Tuesday, July 17, 2012

Is Gammagard the One the Alzheimer's Community Has Been Waiting For?


IVIG (Gammagard) is the first study to report long term stabilization of Alzheimer's symptoms over a period of 36 months.

Alzheimer's Reading Room

Is Gammagard the One the Alzheimer's Community Has Been Waiting For?
We now have the first study in almost a decade that is reporting long term stabilization of Alzheimer's disease symptoms in patients.

Eleven patients who were treated over a 36 month period with IVIG/Gammagard had favorable outcomes in terms of their thinking abilities, behavior and daily function.

To be clear, the already existing symptoms of the Alzheimer's patients being studied did not improve; however, patients did not show any further decline on measures of cognition, memory, daily functioning or mood over the three years.

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There is some good news here. The Phase 3 clinical trial is already in progress and results are expected within a year.

In addition, Gammagard is already an FDA approved drug.

The bad news is if Gammagard does treat Alzheimer's effectively it is likely to cost upwards of $3,000 a month.

Also keep in mind, one of the major limitations of the current research being reported is that the sample size is very small. Nevertheless, what we learned today should give all of us hope.

The researchers found that:
  • Study participants who were treated with IVIG 0.4g/kg every two weeks for the full 36 months (n=4) had the best outcome, with no decline on several standard measures of cognition, memory, daily functioning and mood (ADAS-Cog, CGIC, 3MS, ADCS-ADL, NPI, QOL) at the three year endpoint.
  • As a group, the 11 participants who received IVIG for the full 36 months had favorable outcomes in terms of their thinking abilities, behavior and daily function.
  • The five participants who were initially treated with a placebo and then switched to IVIG declined while on placebo but experienced less rapid decline while receiving a uniform dose of IVIG.
Conclusions:
  • This is the first study to report long term stabilization of AD symptoms with IVIG treatment over a period of 36 months. 
  • Limitations of the study include the small number of participants and the biases inherent in an open label extension study. 
  • The GAP Phase 3 trial is currently in progress and will provide pivotal data on the safety and efficacy of 18 months of IVIG treatment of AD.



Norman Relkin, et al. Three Year Follow-up on the IVIG for Alzheimer's Phase II Study. (Funder: Baxter Healthcare)
Bob DeMarco is the Founder of the Alzheimer's Reading Room and an Alzheimer's caregiver. The blog contains more than 3,711 articles with more than 308,100 links on the Internet. Bob lives in Delray Beach, FL.

Original content Bob DeMarco, the Alzheimer's Reading Room