Study examines whether investigational drug slows Alzheimer’s

William Burke, M.D.

A clinical research study at UNMC looks at whether an investigational medication can slow the progression of Alzheimer’s disease in adults with mild to moderate symptoms.

The Identity-2 Study will help research clinicians determine whether they can block the production of a sticky protein called amyloid in the brain to slow the rate of brain cell death, and therefore the progression of the disease. Researchers believe abnormal accumulation of the protein causes plaque and kills nerve cells in the brain of Alzheimer’s patients.

“It’s an exciting time in Alzheimer’s disease research,” said William Burke, M.D., professor and vice chairman of psychiatry who is leading the study at UNMC. “Our current treatments can help manage symptoms, but this has the potential to change the course of the illness.”

Nearly 27 million people live with Alzheimer’s, but global researchers expect this number to increase to 100 million by 2050.

“Our current treatments can help manage symptoms, but this has the potential to change the course of the illness.” William Burke, M.D.

UNMC will enroll 10 to 20 patients in the phase-three clinical study. In all, up to 1,100 adults in 22 countries with mild to moderate Alzheimer’s disease are expected to participate in the study.

Eligible study participants and their study partner/caregiver will attend up to 20 office visits over 22 months. All study participants will take their current Alzheimer’s medications for the duration of the study. In addition, participants randomly will be assigned to receive either the study medication or a placebo.

Of the eligible study participants, half will receive the active study medication from the beginning of the study. After 64 weeks, all participants will receive study medication even if they previously had taken only a placebo. This delayed start will help researchers determine if the investigational drug slows disease progression.

To be eligible for the study, participants must:

• Be at least 55 years of age;
  
• Have mild to moderate Alzheimer’s disease;
  
• Have a caregiver who spends at least 10 hours a week with the patient, and who can attend study visits, or be available on the telephone at arranged times;
  
• Be able to swallow tablets whole; and
  
• Not have other conditions that may affect participation in the study.

All study-related office visits, physical and neurological exams, laboratory tests and study medications are provided to study participants at no cost while they are in the study. Reimbursement for travel-related expenses such as parking or public transportation may be provided.

For more information, contact Barb Bayer at 402-552-6005 or unmcprc@unmc.edu.