TRAC study: Investigating the effect of trazodone, rapamycin, and cannabidiol on cognitive dysfunction in dogs

Background and purpose of the trial

With the advancements in modern medicine, both humans and canines are living longer and we’re now seeing a greater percentage of dogs suffer from cognitive decline. Currently, there are no approved treatment methods for cognitive decline in either humans or dogs. This study aims to find a safe and effective therapeutic agent for reducing progression of cognitive dysfunction in dogs. Cannabidiol (CBD), trazodone, and rapamycin have shown beneficial effects on brain aging, which means they may be effective therapeutic options for dogs. All three drugs will be tested in order to determine if one, or all, may be a safe and effective medication for reducing the progression of cognitive dysfunction in dogs, with the hope of being able to translate this to humans with Alzheimer’s disease.

Study design

We will be enrolling a total of 48 dogs into 4 separate groups: trazodone, rapamycin, cannabidiol, or placebo. After an initial diagnostic assessment consisting of a thorough exam, bloodwork, radiographs, ultrasound, MRI, and spinal tap, all clients will go home with a liquid medication to be given twice daily and a capsule to be given once weekly. This study is double-blinded, so owners and the clinical trials staff will not know which treatment group each patient is in. All clients will be expected to bring their pet back every 3 months over the course of two years with an MRI being conducted every 12 months (3 total) and a spinal tap being conducted every 6 months (5 total). In addition, some dogs will be randomly assigned to wear an activity-tracking monitor so it’s important that your dog is comfortable wearing a collar at all times!

Commitment

This is a two-year study and it’s important that you’re committed to remaining in the trial for the entirety of the 2 years, unless your pet reaches the end of their life prior to that. You will be committed to giving a liquid medication twice daily, along with a capsule once weekly and will be required to complete a check-in form each week stating that you gave the weekly capsule. It will be extremely important for you to come to the Veterinary Teaching Hospital for your appointments every 3 months and, in addition, to allow your pet to undergo anesthesia at the initial exam, the 6-month exam, the 1-year exam, the 18-month exam, and the final exam.

In the unfortunate event that your pet deteriorates and reaches the end of their life, you will be required to have the euthanasia performed here at CSU and will need to consent to having research samples taken. While this is not pleasant for anyone to think about, it’s extremely important for the study to be able to analyze these post-mortem samples.

Financial incentives

All diagnostics and exams will be covered by the study. In addition, the assigned treatment will be provided for by the study. After the second MRI, you will receive $500 either directly (taxed) or applied as a credit to your Veterinary Teaching Hospital account (not taxed). After the third MRI, and successful completion of the entire study, you will receive an additional $500 either directly or applied to your Veterinary Teaching Hospital account. Additionally, if your pet needs to be euthanized during the study, we will pay for the euthanasia, along with a general or private cremation, depending on your preference.

condition(s)

cognitive dysfunction

eligibility information

Dogs will need to meet the following criteria in order to qualify for this clinical trial:

  • Greater than 8 years old
  • Greater than 22 lbs. in body weight
  • Both cognitive surveys show a score within the “cognitive dysfunction” range
  • Otherwise systemically healthy with no life-limiting disease processes

Enrollment Deadline

Enrollment ends January 31, 2023

contact information

If interested in enrolling, please contact Breonna Kusick (clinical trials coordinator) or Lisa Mulligan (veterinary student researcher) at csuneurotrials@colostate.edu with a brief description of your pet and where we can obtain medical records.

CSU ram head with green background
Breonna Kusick
Clinical Trials Coordinator