Is Your Brain Worth $46/d?

We interrupt your regularly scheduled broadcast of Hope Springs: Thespian Interpretation of Aging Relationships Part 2 for an attempted in-depth analysis of a randomized, double blind, placebo controlled study released early online just 2 days ago by the Archives of Neurology where the authors concluded that 5 months of tesamorelin, a growth hormone releasing hormone, could improve cognitive function in both normal adults & in those with mild cognitive impairment.  

Tesamorelin, sold as Egrifta, has been approved by the FDA since 2010 for use in HIV-associated abdominal lipodystrophy.  The implications of FDA approval cannot be underestimated as it also allows for its off-label use.  As always, make sure you know the potential side effects, risks & downsides before jumping in.  

First, let me give you some background as to my excitement about this new study.  Just 2 weeks ago, Pfizer announced that IV bapineuzumab had failed a phase III trial aimed at preventing Alzheimer's dementia in APOE4 allele carriers.  Then 2 days ago, Pfizer announced that they were, in fact, stopping any further attempts at developing bapineuzumab for use in mild-moderate Alzheimer's disease.

So you can imagine my surprise when these authors randomized 152 adults, avg 68yo, 66 of whom had MCI, to nightly subcutaneous tesamorelin 1mg/d vs placebo, of whom 137 (61 w/MCI) completed the study.  Various standardized measures of cognitive function were assessed at baseline and at 10 week intervals up to 30 weeks total (10 weeks after last administration).  They concluded that tesamorelin improved cognitive function compared to placebo for both those w/baseline normal cognitive function and in those w/MCI.  More importantly, not only did those who completed the study as designed (per protocol) demonstrate improvement, but so did an intention-to-treat analysis including those who didn't finish the trial.  This last point is very difficult to prove but demonstrates real world applicability in that it takes into account drop outs & loss of adherence for any reason.

For those who want to try this on their own, it should be noted that while tesamorelin more than doubled IGF-1 (insulin-like growth factor-1), it was still within the "young adult normal" range.  Moreover, the greater the increase in IGF-1, the greater the executive function composite change scores.  Remember my grade school analogy?  This is akin to tutoring a student from D- to B+ or A-.  

As an added benefit, tesamorelin caused a 7.4% loss in body fat in just 5 weeks!  If you'll recall, I don't use this word "caused" lightly as it implies cause & effect.  But when you analyze an RCT, you're attempting to prove causation, not just association (the only conclusion possible w/observational or epidemiologic studies).  Better yet, fasting glucose, HgbA1c & oral glucose tolerance tests were not affected by tesamorelin, one of the concerns regarding growth hormone.  Finally, tesamorelin leads to a more physiologic pulsatile IGF-1 response as opposed to the constant response from GH.

Now if you've read along, you know that I also look for flukes & trends.  Not that this is the final arbiter, but a February 2006 randomized, double blind, placebo controlled study published in Neurobiology of Aging also demonstrated GHRH (in this case sermorelin) also improved cognitive function in healthy normal older patients.

Bottom line: is your brain health & cognitive function worth $45.99/d?  That's the average wholesale price of a single 1mg vial of tesamorelin, the entire contents (all 1mg) of which was injected subcutaneously daily for 5 months.  Or could you put that daily $46 to better use by eating higher quality foods, exercising regularly, and getting enough rest?

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