Will rapamycin help my dog live longer?
Will rapamycin keep my dog healthier?
How does rapamycin work?
Is rapamycin safe for my dog?
Would I have to medicate my dog his entire life?
Are there any side effects of rapamycin?

We don’t know—YET!

We designed the Test of Rapamycin in Aging Dogs (TRIAD) to answer some of these questions.

Clinical studies in dogs are an essential component of veterinary research and medicine, as well as broader biomedical research. These studies aim to improve the health and well-being of dogs and other animals while offering valuable insights into diseases and treatments that can benefit humans. In the TRIAD study, we hope to evaluate the safety, efficacy, and potential side effects of rapamycin in dogs, leading to improved veterinary care of senior dogs and contributions to the understanding of human aging.

First, do no harm.

Any clinical trial, like TRIAD, has strict inclusion criteria designed to ensure the safety of the participants and the strength of the scientific assessment.

Here are the criteria for TRIAD:

• Age 7 years old or older: To get the best answers to our rapamycin questions, it is important to have as few variables as possible. By inviting dogs seven years old or older,  we will have a sample that, although different breeds, are at the same life stage. We want to study dogs in the middle to late life stage, where this intervention would be most practical and most likely to help.

• Weight 44 to 120 lbs: We know that size affects the rate of aging in dogs. Including both large and small dogs in this study would introduce another variable (size-specific aging rate) and make it harder for us to detect any rapamycin-related effects. In addition, size affects the metabolic rate, meaning that large and small dogs will metabolize drugs like rapamycin differently. For TRIAD, we need to standardize the amount of rapamycin given to dogs in the test group and have confidence that this standard dose will have the same physiologic consequences in all the dogs in the study.
• Spayed or neutered: The eligibility requirements for our clinical trial help us ensure scientific validity and participant safety. Because there are not many studies of rapamycin in dogs, we are also guided by information from other species.  Rapamycin has been shown to cause infertility (which may be reversible) in male people and male mice; effects on female fertility are uncertain. At this time, it is not known whether rapamycin may cause infertility in dogs and whether or not infertility would be reversible. This is why when TRIAD was designed, we decided not to include sexually intact dogs in the study. All participants in our clinical trial are volunteers, and it is important to minimize unnecessary risks. We know some of our participants aren’t planning to breed their dogs. However, balancing the possible risk of infertility – a potentially permanent health consequence – against the lack of any known benefit of rapamycin, we determined it would not be ethical to enroll intact dogs in TRIAD. Clinical trials of promising medications are repeated over time. If our clinical trial finds that rapamycin has a positive impact on healthy aging in dogs, then additional studies will likely follow. These studies may be designed to include populations at particular risk of side effects, such as intact dogs.
• Up-to-date on vaccinations, including rabies and distemper: We want to study generally healthy dogs, which means dogs who receive regular veterinary care to maintain wellness. Vaccinations are necessary to keep dogs healthy and can help avoid costly care for preventable diseases. They prevent diseases that can be passed between animals and from animals to people.
• Up-to-date on heartworm tests and be on or be willing to be on heartworm preventative (state specific): For TRIAD, our goal is to enroll a diverse group of healthy aging dogs with many breeds and geographic areas represented. We have asked TRIAD participants to follow the preventive care guidelines outlined by The American Animal Hospital Association (AAHA), American Veterinary Medical Association (AVMA), and The American Heartworm Society (AHS). Based on these guidelines, we ask all TRIAD enrolled participants to give heartworm prevention at a regular interval (this may be a monthly tablet or monthly topical, or an annual or semi-annual injection), as well as stay current with their distemper/parvo/adenovirus and rabies immunizations. Specific locations of the country see higher prevalences of all of the above diseases, but for standardization, we have asked all participants to follow these guidelines. This also eliminates risk issues with travel, as we have participants who spend part of the winter or summer in other geographic regions of the country. We encourage you to speak with your primary care veterinarian to discuss further the risk in your area of heartworm, and how many cases have been diagnosed in recent years. You can learn more about the AAHA preventative guidelines for dogs here.
• Have no major medical conditions or require regular medications that might interact with the study medication. We want to make sure that we are studying the medication, not all the other things going on with the dog.
• Be non-aggressive and able to remain compliant through lab work, exams, and tests performed at all appointments. TRIAD study appointments require dogs to be examined for several hours, often without their owners present. Dogs may need to patiently lie down during an echocardiogram or participate in a neurological examination, and all dogs need to tolerate blood collections at each visit. Dogs who have repeatedly exhibited stress and anxiety with veterinary appointments are not included in the study, as we feel this would be too stressful for both the dog and veterinary staff. At all of our participating TRIAD sites, it is standard hospital policy that owners may accompany their pets for certain aspects of the screening visit (such as the patient history and blood pressure). Other procedures (such as echocardiogram, neurologic exam, and sample collections) occur within the internal departments of the hospital. For the privacy, safety, and security of all patients and staff within these areas, owners are asked to remain in approved client waiting areas while their canine companions go with the hospital staff. Many of these departments have limited space; thus, it is ideal to keep the number of people present to the minimum necessary. We encourage you to share with the hospital staff any important details about your companion’s personality that can help to create the most comfortable and pleasant experience possible. All the veterinarians and supporting staff at our partnering TRIAD sites are professionally trained, and your dog will be in excellent hands.

It’s more than just the medication.

Additionally, owners will be asked to do the following:

• Transport their dog to the nearest TRIAD clinical site every 6 months after the initial eligibility assessment for three years (seven visits.)
• Maintain regular veterinary care for their dog with their primary care veterinarian.
• Keep a Medication and Observation Diary throughout the first year when administering the study medication.
• Answer surveys and provide information about their dog’s health in a timely manner over the course of three years.

We know that TRIAD participation could seem overwhelming. There is a real possibility that study dogs may not experience better aging health either because they may be receiving the placebo or because rapamycin does not improve aging health in dogs. The fact that we are doing the study doesn’t mean that we know rapamycin has benefits for dogs.  We are studying rapamycin because we don’t know – yet.  Participating in the TRIAD study may not help your dog live longer, but your participation will help future dogs live healthier lives longer. And who wouldn’t want to be a part of that?

The TRIAD TEAM