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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 am 71 and get heartburn every day. I raised the head of my bed and take sucralfate four times a day and also heartburn pills, but I still have trouble. Can you help? – C.M.
ANSWER: Heartburn is usually caused by reflux (backward movement) of stomach acid into the esophagus. First-line treatments are lifestyle, such as raising the head of the bed (which helps by letting gravity pull acid back down when you are asleep, not upright and not swallowing); not eating two to three hours before bed; avoiding foods that worsen symptoms (which kind depends on the person, but frequently includes fatty and spicy food); and weight loss when appropriate.
When lifestyle changes alone are inadequate, medication is reasonable. I don’t know what heartburn pill you are taking, but the proton pump inhibitors, like omeprazole (Prilosec), are generally the first line for people with more than mild symptoms. Histamine blockers, like famotidine (Pepcid) or ranitidine (Zantac), are effective for occasional use.
Sucralfate is not as effective, despite needing to be taken four times daily, and is not recommended except in pregnant women.
Dr. Roach regrets he is unable to answer individual letters, but he will incorporate them in the column whenever possible. Readers may email questions to ToYourGoodHealth@med.cornell.edu.
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