Research Study FAQ

As a clinical research participant, you can proactively manage your healthcare and lead the way for future generations to prevent and treat Alzheimer’s disease. You will join a league of generous volunteers who have paved the way for innovative medical treatments that save lives every day. Other benefits of taking part in clinical research include:

• Close monitoring by a team of leading experts in their specialized fields.
• Access to promising new treatments not available through standard plans of care.
• The chance to play an active role in your own healthcare and gain a better understanding of your condition.

You will first be required to attend initial screening appointments. You will discuss your medical history with the members of the study team. You will be provided with detailed information about the study medication and its potential benefits and side effects. The screening visits may involve health assessments such as blood tests, neuropsychological assessments, and brain scans. Once you complete the screening process and receive approval from the medical team, you will be invited to join a clinical trial, which is also called randomizing into a study. You will be given a study medication at the clinical research site or instructions about how to take it at home. You will be required to attend the clinical research site on a regular basis (approximately once every 4-6 weeks) to receive additional study medication and to have your health closely monitored by the medical team.

The length of your required participation varies for each study. It can be anywhere from 10 to 52 visits, typically about every 4 - 6 weeks. You will receive this information from the study team during the informed consent process. You will have the opportunity to ask any questions and determine whether you will be able to participate in the required number of visits. 

All clinical research studies are subjected to vigorous monitoring by regulatory bodies such as Medicines and Healthcare Products Regulatory Agency (MHRA), Health Research Authority (HRA), European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and Health Canada (HC) to ensure that the study and drugs are being tested in an ethical and safe manner. No study will ever take place in humans without having the appropriate approvals in place.

Cogniciti most often connects volunteers to Phase 2 and Phase 3 clinical trials, meaning that the study medication has been proven safe enough to be used in human volunteers, and the study team will be able to explain the benefits and the risks of participating. Common side effects may include headaches, nausea, skin rashes, etc., which are also commonly associated with taking medications such as Tylenol or Panadol. It is important to remember that all medications, even those currently prescribed by your doctor or pharmacist, come with potential side effects, and have been made possible for use through the clinical trial process.

Most clinical trials include the use of a placebo to help researchers evaluate the effect, if any, the investigational drug has on symptoms. (A placebo is commonly used in phase 2 and phase 3 clinical trials.) A placebo is designed to look exactly like the investigational drug but has no active ingredients.

In randomized clinical trials, participants will receive either the investigational drug or a placebo. Researchers compare the results of the group receiving the investigational drug to the group receiving a placebo to determine if the investigational drug is having the desired effect. The use of a placebo helps to speed up a clinical trial as researchers can more quickly observe any differences between the groups.

Clinical trials are funded by the companies that are developing the new treatment. Since the treatments are not yet on the market, volunteers receive the study medication, medical tests, assessments, and all aspects of care surrounding the clinical trial, free of charge.

Most treatments tested in clinical trials are not yet on the market, meaning that they are not available in pharmacies and cannot be requested by medical prescription. It might take years before the medication tested in clinical trials is available on the market, because it is required to be tested in all the phases of the clinical trial and be shown as effective. Having early access to new treatments which may slow down the progression of Alzheimer's disease is one of the many benefits of participating in a clinical trial. 

Many clinical trials for Alzheimer’s disease compensate you for your time and travel. You also get the benefits of free access to health monitoring by a team of medical specialists and a more accurate diagnosis of your condition if you have an onset of cognitive impairment.

There are two types of Alzheimer's disease clinical trials:

Treatments aimed at reducing symptoms. During this type of trial, new drugs and variations of existing drugs that aim to reduce the symptoms of Alzheimer's disease are tested. Studies of existing drugs explore whether changing the dose, taking the medication on a different schedule (more or less often), or combining it with other medications might further reduce or delay symptoms.

Treatments aimed at slowing or stopping the disease. During this type of trial, new drugs designed to slow or stop Alzheimer's disease are tested. Some of the experimental drugs being tested in clinical trials represent entirely new ways of treating the disease.

Treatments that are aimed at slowing or stopping the progression of disease have different biological targets, which fall under seven categories:
 

• Genetics & Epigenetics: These therapies may target certain genes, such as APOE, which can affect our risk for Alzheimer’s disease. Epigenetic processes regulate how much our genes are expressed.
• Inflammation: Chronic inflammation in the brain can accelerate Alzheimer’s disease and may be a trigger of the disease. That said, inflammation is also part of our normal immune responses and can protect the brain from damage.
• Misfolded Proteins: In Alzheimer’s disease, proteins including beta-amyloid and tau can misfold and become toxic. These misfolded proteins accumulate into plaques, tangles, and other aggregates if not cleared by the brain’s self-repair mechanisms.
• Mitochondria & Metabolic Function: All cells need energy to maintain healthy function, and neurons (i.e., brain cells) are among the highest energy users. As we age, mitochondria, the energy center of our cells, can become impaired as can other aspects of cellular metabolism.
• Neuroprotection: As Alzheimer’s disease progresses, neurons lose their connections and begin to die, causing the loss of memory and other essential cognitive functions. Neuroprotective strategies attempt to shield neurons from multiple causes of damage and death.
• Synaptic Activity & Neurotransmitters: Synapses are connections between our neurons. Neurotransmitters carry chemical signals across synapses, which is critical for memory and cognition.
• Vascular: Healthy blood flow is required for optimal brain function. Vascular damage can affect how misfolded proteins and toxins are removed and can limit the ability of neurons to get sufficient oxygen and vital nutrients.

The medical and research team will indicate your eligibility for a particular study. The study you will be invited to participate in will depend on a combination of factors, such as the progression of your memory impairment, your scores on neuropsychologial assessments, and your medical history. The medication provided by each study targets a specific area of memory impairment that you will be matched against to ensure the study is a good fit for you. 

Based on the results of your health assessments, the research team will make sure that there are no dangerous side effects for your individual health. They will look at the current medication(s) you are taking and your present and past health conditions to ensure that the drug will have the most optimal results and the least detrimental effects.

Most Alzheimer's disease and dementia studies will require you to have a study partner. This can be a family member, a caregiver, a friend or someone who is able to provide information about your daily living. Depending on the study, the study partner will be also required to attend most of your appointments. They will not be required to take any health assessments; however, they will have to be able to provide information about you and monitor your health progress when needed.

As there is no contract or fees attached to your participation in clinical trials, you can opt out of a study at any time. You can do this just by letting the research team know. They will provide advice about how to stop your medication and whether you need to follow up with your healthcare professional.

All the data is obtained for research purposes only and is kept completely confidential. Any changes in your cognition, memory and overall health is closely monitored to determine whether the treatment is effective and to observe how you respond to the medication. The data is used by a team of scientists to compare how participants in the research study respond to the investigaional treatment.