DEAR DR. ROACH: My wife has had dementia for over two years. There is an ad in our local paper for an Alzheimer’s disease study. It says, “This study will assess how safe and effective an investigational drug is at slowing the progression of early (prodromal) or mild Alzheimer’s disease.” Is this protocol legit? I don’t trust this type of ad not coming from a hospital. I couldn’t find any information about the sponsors of the research. — J.N.
ANSWER: I was able to find the trial, called the Graduate II trial, which is sponsored by the manufacturer of the drug being tested, called gantenerumab. This drug is designed to reduce the size of the amyloid protein plaques in the brain, which are suspected of being the underlying cause of Alzheimer’s disease, and to prevent new ones from forming. It is indeed a legitimate trial.
The best place to find out about these is on the clinicaltrials.gov website. The trial is in phase III. The drug has passed both phase I trials, which are designed to look at safety, and phase II, which look at both safety and effectiveness.
Now the investigators are studying the effectiveness of the drug in a larger population, usually for a longer period of time. Drugs that do well in phase III clinical trials may be approved by the Food and Drug Administration. Alzheimer’s drug trials are difficult, because the disease often progresses slowly, and large, time-consuming trials are necessary. In general, I encourage people to consider participating in clinical trials, as they are essential for clinical advances.
For gantenerumab in particular, phase I and II trials did show that the drug is effective at reducing the amount of amyloid plaque in the brain; however, clinical trials did not show improvement in memory and brain function. The new trial is using a higher dose and recruiting patients with earlier stage illness. I don’t have enough information to answer whether your wife, having had symptoms for two years, might be eligible for this trial, but I would certainly encourage you to find out more about it.
DEAR DR. ROACH: I have recently started transitioning to a plant-based diet for preventative health reasons. While discussing the benefits of nuts and seeds with a dietitian, they had a disclaimer that flax seed can interfere with medications and to eat them two hours before or one hour after taking medications. I would not sit down and eat a handful of flax seeds, but now I am afraid to use them in the meals I prepare at all. Can you help me make a good decision? — J.E.
ANSWER: For people eating reasonable amounts (like a handful or two) of flax seeds as part of a meal, it is unlikely that they would interfere with medications enough to cause any significant problem, for most medications. There are two situations that might merit concern: In powerful anti-clotting agents, such as clopidogrel, flax seeds might prompt increased activity. Secondly, flax seeds may lower blood sugar a small amount. In combination with insulin or oral diabetes drugs, the blood sugar could possibly dip lower than expected. I doubt either of these interactions is likely to cause harm, but it is reasonable to discuss with your doctor if you are on one of the classes of medications mentioned.