New Alzheimer's Disease Treatment: The Search Is On

Alzheimer’s disease is the most common cause of dementia, a chronic condition marked by memory loss and a decline in mental function. Approximately five million Americans suffer from mild to moderate forms of the disease, but the numbers are still growing. Current treatments for Alzheimer’s include medicines that delay or slow down mental decline and memory loss, but no cure has been found. These medications include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine), for mild to moderate cases and memantine for more severe symptoms. These drugs work differently and they may be used in combination for temporary improvement of daily functioning.

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Other medications may also be used to treat sleep problems, anxiety, hostile behavior, delusions, paranoia, and hallucinations, which sometimes occur in people with Alzheimer’s.

Alzheimer's Treatment: New Clinical Trials

After initial studies (Phase I, 2005) involving animal models showed that T-817MA  promotes nerve cell growth and improves memory loss, a Phase II investigation involving human clinical trials was conducted between 2008 to 2011. The multicenter trial called Alzheimer's Disease Cooperative Study (ADCS) covered Alzheimer’s patients in US and Canada and compared the effects of a daily oral dose of T-817MA (224 mg) to placebo in more than 300 patients who were already taking donepezil. The researchers measured cognitive (mental) function as the primary outcome and safety and overall effects as the secondary outcome.

To further evaluate the effectiveness and safety of T-817MA, a new trial called NOBLE was started in March 2014, using a randomized, double blind study design with a control group. This means that randomly selected Alzheimer’s participants will receive either the active drug or a placebo (a substance with no active drug). Neither the patient nor the researchers will know what the patient is receiving until the conclusion of the study, when results are analyzed. The research, which is being conducted in multiple test centers in the US, is led by Dr Paul Aisen, a leading expert in Alzheimer’s disease in the US.

The study will last for 2 years and will include 450 patients of both genders between the ages of 55 and 85 years.  Enrolled patients include only those who have been diagnosed with mild to moderate Alzheimer’s disease and are taking the standard treatment for at least six months; they must have a body weight of not more than 220 pounds, live in a community (not a nursing home), and have a partner or a regular caregiver who may accompany them to the study visits. Patients who have clinically significant medical conditions or are taking any drug aside from donepezil or memantine (such as rivastigmine or galantine) for Alzheimer’s disease are excluded from the study.

For the study, participants are randomly assigned to one of three groups. One group receives 224 mg of T-817MA, another receives 448 mg of the same drug, and the last group receives placebo, which is an inactive substance. Researchers conduct tests to determine the drug’s effects on the patients’ memory, other mental aspects, and daily functioning. Aside from these, participants also undergo physical exams, some blood tests, and MRI (brain scan).

The Burden of Alzheimer’s Disease

Elderly individuals comprise a large portion of the population and their risk for developing Alzheimer’s disease significantly increases as they age. The Alzheimer’s Association reports that someone develops Alzheimer’s every minute. More than 5 million Americans are living with Alzheimer’s disease. Two-thirds of patients are women. Studies also show that women are twice more likely to die of Alzheimer’s disease than from breast cancer. In 2013, unpaid care valued to exceed $220 billion was provided by more than 15 million caregivers in more than 17 billion hours of service.

Aside from treatment of the disease, scientists are also looking into the possibility of finding preventive therapy for Alzheimer’s disease. One trial, called “A4, ″ is going to evaluate the effects of an anti-amyloid treatment in healthy individuals who have an increased risk of developing the disease, based on PET scan findings that show amyloid protein elevations. The drug, called Solanezumab (manufactured by Eli Lilly & Co.), is the first of its kind to be used for the prevention of the disease.

Recommendations

Although there is still no known treatments to prevent Alzheimer’s disease, studies suggest that there are ways that you can do to reduce your risk. Research shows that physically active adults are less likely to have dementia.  Current recommendations consist of doing moderate levels of physical activity for at least thirty minutes per day on most days of the week. Aside from physical activity, studies also indicate that staying mentally active through reading, listening to music, watching TV, or playing card games may also help lower your risk for Alzheimer's. Going out with friends and remaining socially active are also associated with good mental health.

At present, no cure has yet been found for Alzheimer’s disease. Current treatments aim to delay progression of the disease and to optimize one’s functioning in daily living. Coping with a family member who has Alzheimer’s disease can be demanding in terms of physical and emotional burden. On top of these, financial costs and the difficulty of deciding whether to transfer one’s care to a facility can be too much to handle. However, new information about caring for people with Alzheimer’s is now available to help and support caregivers and family members. It is therefore necessary to be well-informed about this disease as a long-term strategy to deal with the difficult challenges, to develop good coping skills, and cultivate strong support from a network of family and friends. Caregivers must stay physically and socially active to cope with the physical and emotional demands of their job. This may also include participation in a support group to share experiences, express concerns, get tips, as well as accept emotional comfort. There are many organizations that offer online as well as personal support across the country.

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Researchers are also calling on people with mild to moderate Alzheimer’s disease, as well as their families, to participate in on-going clinical trials that may help find effective and safe treatments for the disease. There are many research centers located in hospitals and clinics that are accepting enrollments to the study, which includes screening, study treatment, evaluation and follow up.