Current Situation

Currently available treatments for Alzheimer’s Disease are inadequate and are aimed at alleviating patient’s symptoms. They are only effective in some people and for a limited time. 

The clinical trials we conduct follow a rigorous methodology guided by a strict research protocol. Before a drug is accepted by governmental control agencies for human use, several trials must be conducted in a pre-established order. When the research trial is complete, the data is analyzed to determine if the drug is safe enough and effective. Health Canada must approve use for all new medications.

Clinical research is the only way to find new treatments!

clinical research

The different phases of research

There are four phases of clinical research. Continue reading below to learn about each phase.  

1

Phase I clinical trials are studies with fewer participants, they typically involving 20 to 80 participants. These participants are usually healthy volunteers who have no underlying conditions. This phase of research aims to determine the highest dosage of the investigational product a human can take without serious side effects. Participants are very closely monitored as the main goal of this phase is to determine the safety of the investigational product.

2

Phase II clinical trials typically involve several hundred participants that are living with the condition that the investigational product is aimed to treat. Generally speaking, phase II studies involve comparing individuals given the investigational product to those given placebo. A placebo looks like the investigational product but has no active ingredients. In Phase II studies, participants are monitored over a longer period (typically several months to years) to see how safe and effective the investigational product is and to gather longer term information about any potential side effects. These studies are typically double-blinded, which means that neither the participant nor the physicians/study staff know if a participant is receiving the placebo or the active investigational product.

3

Phase III studies are typically large-scale, global studies that involve hundreds or thousands of participants that have the condition the investigational product is meant to treat. For Alzheimer’s Disease, these studies typically last 6 months to 3 years. They are designed to gather long-term information about both safety and efficacy of the investigational product under study and involve a group receiving the investigational product and a group receiving placebo. This is done to tease apart the efficacy of the medication when compared to not receiving the investigational product (or to compare it to the standard of care that is available to treat the condition under study). Phase III studies are critical to clinical research as their longer duration and larger number of participants allows detection of rare and long-term side effects to show up and provide overall information on safety and efficacy (how well it works to treat the condition). Just like phase II studies, these studies are typically double-blinded.

4

Phase IV clinical trials are conducted after a medication has already received Health Canada approval to be marketed. This means that the investigation product is now a medication proven to be safe, effective and achieved predetermined outcomes. Phase IV studies are very long studies and involve even more participants than Phase III. This phase of clinical research is used to gather longitudinal information about a given medication in terms of safety, efficacy, and other potential benefits.

It is important to note that the data and information collected during all phases of clinical research are used to contribute to the development of the next stage/phase.

The field of life sciences is booming. Innovation is at the heart of treatment possibilities for patients. Ontario and Québec are popular destinations for research and many clinical trials are launched each year.

Several experimental treatments are currently being evaluated in clinical trials and may prove to be effective in the prevention and treatment of Alzheimer’s Disease.