There are many reasons a loved one with Alzheimer’s or dementia might participate in clinical trials. Doing so can give access to the newest drugs that might slow or hopefully even reverse the progression of the condition. New therapies might improve the participant’s emotional well-being. The attention and quality of care the participant receives from the study doctors and nurses may be significantly higher than from their own medical professionals. Participants and their family members and caregivers can also receive monetary compensation for their efforts. Altruistically, patients and their family know that by participating they are helping to fight Alzheimer’s disease and other dementias such as Vascular, Lewy Body, Frontotemporal Dementia and even Mild Cognitive Impairment (MCI).
The decision to join a clinical study should not be made lightly. There are many factors participants and their family members or loved ones should consider prior to joining. First and foremost, families should understand the reason the medical professionals are undertaking the study. It may not be necessary to understand the medical chemistry or pharmacology involved, but a larger picture understanding of what the study is trying to accomplish is in order. Further, families need to know what specific information about the participant will be required. Knowing this in advance will help to offset any future privacy concerns the participant may have.
The logistics of the study are important to knowing the level of commitment required of the participant. It should be noted that clinical trials for dementia and Alzheimer’s often require a commitment from the primary caregiver as well, as examples, transportation assistance and medication management. The duration of the study, the phase of the trial (more on this follows), the frequency of medical visits or therapy sessions and the length of each visit all impact the participant and their caregiver.
There are three phrases of clinical trials that involves testing with human participants (prior to human testing, animal testing typically occurs).
Phase I Trials – To minimize risk to participants, new drugs are introduced to very small groups of individuals. Phase I trials are primarily intended to ensure the medication is safe and to determine what, if any, side effects it may have. Participant group size is less than 100 persons.
Phase II Trials – Phase II trials continue the objectives of Phase I, identifying safety and side-effects, except they work with a larger sample set, up to 300 people. In addition, in Phase II researchers also begin to study the effectiveness of the drug.
Phase III Trials – Again, the objectives of determining safety and side-effects continue. However, by this phase these have been fairly well determined. Researchers are seeking greater statistical certainty by expanding the trial to a larger sample size. By Phase III, the primary objective is determining the effectiveness of the medication and also comparing that effectiveness to other drugs or treatments. Phase III trials, especially those treating persons with Alzheimer’s or dementia, may have as many as 3,000 participants.
Although it is not a concept without controversy, clinical trials have a long history of compensating their participants. Participants are compensated for travel, expenses, loss wages and outright payments for their time. Frequently compensation is intended to speed recruitment and discourage attrition. Losing participants mid-study is a major problem for researchers.
The amount of financial payment made to participants depends on many factors. The rarity of the condition, the market size for the drug, the speed which the pharmaceutical company wants to recruit participants and also the phase of the trial. Typically Phase I trials offer higher compensation than phrases II or III. Participants have been known to receive compensation from as little as $50 to as much as $5,000.
Compensation should not only be thought of in financial terms. For many participants, they receive a higher level of care than they otherwise would have received from their primary care physicians. Obviously, this is not always the case, but for some the incentive in participating is the better care.
There are many considerations when looking to participate in a clinical trial for Alzheimer’s Disease or other dementia. Location and timing are critical. Participants must be diagnosed for the specific type of dementia as well as the phase of the condition on which the doctors are performing their research. Interested parties should be aware that both the search for an appropriate trial and participation can be very time-consuming.
The National Institute on Aging offers a search tool for dementia-related clinical trials here. Readers should be aware that the trial descriptions are often confusing.