Opportunities for Manufacturers
to Address Unmet Needs in Alzheimer’s Disease and Newly Emerging Area of MCI

By Kim Lazarus, Vice President,
GfK Market Measures

November marks National Alzheimer’s Awareness month, providing a timely opportunity to share some of what we have learned in the Alzheimer’s disease category drawn from GfK Market Measures’ recent Therapeutic Class Studies. This article aims to provide insights from some key stakeholders by taking a closer look at the physicians in the commercial environment and caregivers of Alzheimer’s patients to learn about mild cognitive impairment (MCI). As the category evolves, the question of whether the stages of Alzheimer’s disease will remain as mild, moderate and severe or come to include the newly emerging area of mild cognitive impairment remains a question yet to be answered. On the other hand, MCI may become its own independent disease state. To provide clients with information on this topic, we have begun to investigate this question within all our Alzheimer’s studies. The following is a brief overview of some interesting findings from this exercise thus far.

Initially, when we talked with Alzheimer’s caregivers in 2007, one-quarter of caregivers recall that a physician had suspected their Alzheimer’s patient had, at one time, been afflicted with mild cognitive impairment. In nearly two-thirds of these cases (62 percent), the patient was placed on an Alzheimer’s medication, with caregivers equally likely to report that treatment was given either immediately following the MCI identification or prior to the actual Alzheimer’s disease diagnosis. In addition, from the caregiver perspective they report that their loved one was overwhelmingly placed on Aricept as the treatment of choice for MCI, with over two-thirds of caregivers reporting its use in these instances. This usage of Aricept is despite the fact that neither Aricept nor any other brand currently has an indication for MCI. On the other hand, from the caregiver’s perspective, one-third of the patients suspected to have MCI are not given a medication until their Alzheimer’s diagnosis is officially made. This represents a notable untapped portion of the marketplace. We should look closely at what the caregiver is telling us to learn whether the physician is using MCI to “soften” the Alzheimer’s diagnosis or seeing this as part of the evolution of the Alzheimer’s disease or seeing MCI as a separate disease (see figure 1).
Figure 1


We then turned our attention to GfK Market Measures’ 2007 Alzheimer’s Physician Study to determine what the physician’s perspective is between MCI being an early stage of Alzheimer’s or a distinct disease. The response we received is that half the physicians believe MCI was an early stage of Alzheimer’s disease (see figure 2).

Figure 2


Meanwhile, more than one-third of physicians indicate they are unsure of the relationship between MCI and Alzheimer’s disease. Psychiatrists (52 percent), in particular, are the specialty most likely to be unsure of the relationship between MCI and Alzheimer’s disease. One GP/FP stated: “Most patients eventually develop mild cognitive impairment. Often difficult to distinguish between very early Alzheimer’s and MCI. There is significant overlap between the two in older patients.” Clearly the physicians would benefit from manufacturers helping them understand the relevant differences and enabling them to make a diagnosis in a cost-effective and timely manner. This would enable them to provide excellent patient care at an early stage and hopefully delay the loss of cognition.

Importantly, as manufacturers look toward the issues surrounding MCI, our research among physicians clearly suggests that they do have a somewhat difficult time distinguishing MCI from early stage Alzheimer’s disease, particularly psychiatrists and PCPs (see figure 3).

Figure 3


In fact, one in five physicians report having a very difficult time making the distinction. The difficulty is often attributed to the unpredictability of the progression of cognitive decline. It is also difficult for physicians to assess the level of the patient’s functional status and cognitive decline, which is often a result of challenges in obtaining accurate information from patients and family members. One neurologist stated: “Obtaining good history of patient’s patterns of behavior from family can make the diagnosis more easy; this is difficult sometimes.” This helps demonstrate the importance of the caregiver and physician dialogue at the point of care. Making a distinction between MCI and mild Alzheimer’s takes time, and it isn’t something that can necessarily be done during a single evaluation. One neurologist clearly stated: “No clear diagnostic criteria are available” either to distinguish MCI from Alzheimer’s or from normal age-related forgetfulness. Therefore, a major opportunity exists for a manufacturer to help physicians establish a simple diagnostic procedure to permit regular screening of all their older patients (potentially 65+).

Diagnosis of mild cognitive impairment does seem to be reported fairly equally among all physician types. However, upon diagnosis, physicians often do not treat their MCI patients with current cognitive therapy, particularly those diagnosed by PCPs. Among MCI patients who do receive treatment, Aricept remains, by far, the most common choice (which is unchanged from our study conducted last year). Thus, Aricept is the product most associated with treating MCI and it will likely remain the therapy of choice for these patients in the near future, despite its lack of an indication for MCI. The volume of untreated MCI patients presents an opportunity for Aricept or any new drugs if they can show efficacy among these patients (see figure 4).

Figure 4


Physicians currently estimate that 60 percent of MCI patients move on to having Alzheimer’s disease. The market is eager to find a medication to improve MCI and thus slow down the progression to Alzheimer’s for the many who are expected to progress to the disease. Clearly, slowing the progression of the disease at this early stage would prolong the time a patient would be able to lead a more productive life and remain living in the community.

In summary, GfK Market Measures will continue to track the MCI question along with the Alzheimer’s category to help ensure that we all stay on top of its evolution. In the meantime, the opportunity for pharmaceutical marketers is to respond to the needs of both the caregivers and physicians, who will require additional education on the signs and symptoms of MCI as well as Alzheimer’s disease and how these differ from normal aging.


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