It’s fair to say that progress these last few years in treating Alzheimer’s has been, in a word, disappointing. It’s a huge problem that is about to get even worse with Baby Boomers entering their 60’s and 70’s, unless researchers make inroads in how to reduce or maintain the build-up of beta amyloid proteins (or what is often called ‘plaque’) that takes place in the brain in people with the disease.
The results of a new study, while 'small’, is the most encouraging I have ever heard about. The results of a larger study will be released in mid-2013. This one could be a game changer.
Below is an excellent overview, written by Dr. Mark Niedfeldt in his monthly newsletter to his patients. Dr. Niedfeldt is an outstanding concierge doctor that’s part of ModernMed and who practices in Mequon, Wisconsin. He has agreed to let me show it here:
Treatment prevented progression of the disease
This is a very interesting, and potentially promising small study of a treatment which seemed no halt the cognitive decline in Alzheimer’s disease.Three years of treatment with intravenous immunoglobulin (IVIG, GammaGard) prevented further cognitive decline in patients with Alzheimer’s disease.
Summary of findings:
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As measured by multiple standard instruments – the Alzheimer’s Disease Assessment Scale (ADAS-Cog), the Clinical Global Impression of Change (CGIC) index, the Neuropsychiatric Inventory, and others – the four patients who received the full 36 months of treatment at 0.4 g/kg every 2 weeks showed no decline in scores, reported Norman Relkin, MD, of Weill Cornell Medical College in New York City.
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The treatment was “generally well-tolerated” but did cause some adverse effects.
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A phase III study with 390 patients is already nearing completion, with results expected by mid-2013
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The rationale for IVIG in Alzheimer’s disease is that it contains antibodies against beta amyloid proteins and it also modulates immune function to reduce inflammation.
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The current report covered a second open-label extension of an earlier placebo-controlled, double-blind trial that initially lasted 6 months, involving 24 patients with mild to moderate Alzheimer’s disease (baseline Mini-Mental State Examination scores of 14 to 26).
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As a phase II study, it tested multiple doses and schedules.
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Participants were allowed to receive an additional year of open-label treatment with IVIG. With continued favorable results – including inhibition of brain atrophy as well as cognitive protection – a second 18-month extension was offered, with 21 patients accepting. These included all 16 initially receiving IVIG and five of the placebo group.
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The second extension essentially confirmed the earlier findings and showed that the benefits last 3 years.
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Patients initially assigned to placebo showed continued decline in cognitive function, but there was “a bend in the curve” when they were switched to IVIG, reflecting a slowing in decline.
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Pooled data for the 16 patients in the original IVIG groups showed a significant protective effect relative to the initial placebo group.
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The 3-year ADAS-Cog and CGIC scores in the four patients who received 0.4 g/kg every 2 weeks throughout the study were the same as at baseline. This is remarkable because untreated Alzheimer’s disease patients always show measurable decline in 3 to 6 months.
- The author stated “if we have a patient who goes out to 18 or 24 months without changing, usually we begin to doubt that they have Alzheimer’s disease. If we have two patients like that in our practice, we begin to doubt our own diagnostic prowess. To have four patients… all of whom are effectively unchanged after 3 years, is a remarkable result.”
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The findings were from very few patients, and therefore very preliminary. “It’s a very important point because this agent is in limited supply, and the indications for which it is approved, some of them represent disorders in which patients can only survive by getting this particular product. So we don’t want to bankrupt the available supplies."
This preliminary study has gotten a lot of interest because it is really the first study that has shown promise in the treatment of Alzheimer’s disease. Anyone who has had a loved one with this disease understands the devastation it causes to the individual and their loved ones. Basically, the IVIG treatments seemed to halt the progression of the disease, at least over the short term. We don’t know what happens when people stop the infusions. We don’t know at which point it is helpful to use the infusion. Since this is a very small study, there are a lot of unanswered questions. Hopefully, the ongoing trial will give more information. With an incidence of 1 in 8 older Americans projected to have this disease at a cost of over $200 billion annually, certainly any treatment that could halt or slow the progress is potentially helpful. IVIG is a collection of antibodies naturally made by plasma cells in our bodies. It is formed by taking the IgG antibodies from over 1,000 donors and mixing them together. It has been used for immune deficiency disorders, inflammatory disorders and some acute infections. It works by suppression of harmful inflammation. There is a limited supply of IVIG and it is often used for life-threatening diseases.
Again, this study demonstrates that inflammation in its many forms is harmful. Yet another reason to avoid it when ever possible through healthy diet and exercise.
Relkin N, et al "Three-year follow-up on the IVIG for Alzheimer’s phase II study” AAIC 2012; Abstract P3-381.
Source: http://www.medpagetoday.com/MeetingCoverage/AAIC/33780