It wasn’t all that long ago that there wasn’t much to report on as far as advances in diagnosis and treatment were concerned. The research studies weren’t finding much success in treatment as they moved through clinical trials. There were many studies that were stopped because they showed no significant positive outcomes. At that time the major players in research decided to start sharing their studies to determine if they could better make progress through collaboration. Still, the trials continued to fail.
Over the past year, there has been some success in screening in primary care, diagnostic tests to determine the presence of Alzheimer’s disease, and treatments for those with Mild Cognitive Impairment, and early stage of the disease. Although none of these three initiatives even mention a ‘cure’ for AD, they are identifying cognitive decline in people at the primary care level, having definitive diagnostic tools to determine if cognitive decline is the early stages of dementia, and finally, a new treatment to slow cognitive decline in the early stages of the disease. The earlier that diagnosis can be confirmed, the better the chances are of delaying the catastrophic effects of Alzheimer’s disease.
Self-Administered Screening Tool for Cognitive Dysfunction
Primary care clinics at two Cleveland Clinic hospitals are screening Medicare patients 65 years old and older for cognitive dysfunction during their annual check-ups using a validated homegrown pair of test modules known as the Cleveland Clinic Cognitive Battery (C3B). Taken independently without supervision using a tablet computer with headphones, the screening test fulfills Medicare requirements for cognitive assessment as part of an annual wellness visit.
After the patient completes the battery – typically less than 15 minutes – results are automatically adjusted by age, sex, race, and education level and transferred to the electronic medical record. They are immediately available to the patient’s physician, allowing for follow-up to be promptly scheduled for those identified at risk.
The C3B consists of two self-administered parts: a visual memory test (recalling the location of pictures on a grid) and a processing speed test (matching numbers to symbols). Dr. Rao, who led the C3B’s development, adds that not only does the test perform significantly better than commonly used cognitive screening assessments, but is far more reliable than reports of suspected mental decline from patients or their relatives. “Having a more accurate screening test reduces the waste of resources on unnecessary follow-up testing and neurological referrals,” he says.
“Recognizing mild cognitive impairment and early dementia before manifestations become obvious is a national imperative,” says Dr. Anstead, “especially now that we have identified lifestyle modifications and developed pharmaceutical interventions that are most effective when started early. Making highly sensitive and easily administered cognitive screening a routine part of Medicare annual wellness visits can be a game changer in detecting more people who can still take steps to achieve longer independence.”
(Self-Administered Screening Tool for Cognitive Dysfunction Rolled Out in Primary Care Clinics. July 15, 2024, https://consultqd.clevelandclinic.org)
Revised Criteria for Alzheimer’s Diagnosis, Staging Released
Diagnosing Alzheimer’s disease originally was accomplished by autopsy. There weren’t any reliable means to diagnose the symptoms that AD presented. Examining cerebral spinal fluid was the next diagnostic procedure developed but that was an invasive procedure. Then the use of imaging (PET scans) allowed for a more reliable diagnosis. That is why the development of blood tests has changed the game.
A workgroup convened by the Alzheimer’s Association has released revised biology-based criteria for the diagnosis and staging of Alzheimer’s disease including a new biomarker classification system that incorporates fluid and imaging biomarkers as well as an updated disease staging system.
This statement means that a blood test has been developed to define the disease biologically rather than from symptoms. The revised criteria define Alzheimer’s disease as a biological process that begins with the appearance of Alzheimer’s disease brain pathology before the presence of symptoms of the disease develops.
The information that can be obtained through these blood tests, can track the progress of the disease and increase the confidence that AD is contributing to the symptoms the person is experiencing. These diagnostic tools can allow physicians to diagnose and then follow the progression of Alzheimer’s disease. Currently, these tests are intended for the evaluation of symptomatic patients, not cognitively unimpaired individuals.
The Future of Alzheimer’s Disease Treatment
With the recent FDA approvals of lecanemab and donanemab, two groundbreaking monoclonal antibodies targeting B-amyloid proteins, the landscape of Alzheimer’s disease therapy is evolving rapidly. Jagan Pillai, MD, PhD is a clinician scientist who specializes in neurodegenerative conditions including Alzheimer’s disease. Dr. Pillai will discuss the lessons learned from the two medications.
Lecanemab was released in July 2023 for the treatment of mild Alzheimer’s disease. There is still discussion about the effectiveness of this drug in real-world applications. It was the first monoclonal antibody or anti-amyloid therapy targeting B-amyloid to treat Alzheimer’s disease.
In July 2024, a second monoclonal antibody was approved for the treatment of mild Alzheimer’s: donanemab. Both lecanemab and donanemab are part of a new class of medications for AD called anti-amyloid therapies. In research, both drugs slowed down the progression of the disease in its early stages.
There are differences in how the medications target amyloid, a protein that builds up in the brains of those with AD. A third difference is the frequency of potential side effects of lecanemab versus donanemab. There are pros and cons for each of these medications, but they allow physicians to choose the best treatment for each individual.
These advances in screening, diagnosing, and treating Alzheimer’s disease are exciting but they are just the beginning of breakthroughs. Research continues at a rapid pace because there is still no cure for Alzheimer’s disease.
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References:
Brooks, M. (June 28, 2024). Revised criteria for Alzheimer’s diagnosis, staging released. Retrieved from https://www.medscape.com/viewarticle/revised-criteria-alzheimers-diagnosis-staging-released-2024a1000c4g?mc_cid=e16b439e0a&mc_eid=85ea55bfd3
Cleveland Clinic. (June 15, 2024). Self-administered screening tool for cognitive dysfunction rolled out in primary care clinics. Retrieved from https://consultqd.clevelandclinic.org/self-administered-screening-tool-for-cognitive-dysfunction-rolled-out-in-primary-care-clinics?mc_cid=e16b439e0a&mc_eid=85...
Pillai, J. (July 22, 2024). New Alzheimer’s disease treatments: expert insights on lecanemab and donanemab therapies. Retrieved from https://thewomensalzheimersmovement.org/new-alzheimers-disease-treatments-expert-insights-on-lecanemab-and-donanemab-therapies/?mc_cid=e16b439e0a&mc_e...
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