FDA Approves GE’s DaTscan to Detect Dementia with Lewy Bodies

GE Healthcare announced on November 3 that patients suspected of having Dementia with Lewy Bodies (DLB) now have new FDA-approved imaging options to diagnose DLB definitely. This kind of dementia is sometimes called LBD or Lewy Body Dementia. GE’s DaTscan (ioflupane I 123) has been used to confirm a diagnosis of Parkinson’s disease in over 1 million patients.

One of every five dementia patients has Dementia with Lewy Bodies, and DLB is the second most common form of degenerative dementia after Alzheimer’s disease.

This new approval adds a powerful diagnostic tool for patients exhibiting dementia symptoms suggestive of Dementia with Lewy Bodies. Until now, no definitive diagnostic test was available, and a brain autopsy after death was the only method to confirm a suspected diagnosis. Its approved use for DLB diagnosis is in addition to its use with single photon emission computed tomography (SPECT) imaging to visualize dopamine transporters (DaT) in the brains of adult patients with suspected Parkinsonian syndromes.

Dementia with Lewy bodies often presents atypical symptoms and signs that overlap with other kinds of dementia — leading to frequent misdiagnosis — up to 70% of DLB patients are misdiagnosed and are often mistaken as having Alzheimer’s disease. Early, accurate diagnosis is essential for both the patient and their caregivers. Then, the patient receives the definitive treatment they need, and caregivers can better care for their family members and plan for the future.

Professor James E. Galvin, MD, MPH, Consultant, University of Miami Miller School of Medicine, explains, “Misdiagnosis is a significant issue for those patients with suspected Dementia with Lewy Bodies, causing untold anxiety for the patient and family as well as potentially placing the patient at higher risk of adverse events due to delayed diagnosis. The label expansion for DaTscan moves patients a step closer to an earlier, more accurate, diagnosis which is beneficial for them and their families, setting them on the right treatment path sooner and helping to avoid medications and treatments that could be potentially harmful.”