Clinical experts have published the first set of clinical guidelines for appropriately using the newly approved Alzheimer’s drug aducanumab — brand name Aduhelm.
Although a leading eldercare physicians group has recommended against prescribing Aduhelm to the nursing home population, clinicians may use their own discretion in recommending the drug to patients. The Food and Drug Administration has restricted its use to patients with early disease, mild cognitive impairment or mild dementia due to Alzheimer’s.
The newly published clinical guidelines fill the gaps between the FDA’s prescribing information and “real-world implementation of this treatment,” said first author Jeffrey Cummings, M.D., Sc.D., of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada Las Vegas.
There is an urgent need for a consensus protocol for U.S. clinicians prescribing Aduhelm, said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer. The new guidance is “an important starting point,” and will serve as the basis for additional tools to educate and support both primary care physicians and dementia specialists, she added.
“Aducanumab: Appropriate Use Recommendations,” was published online by The Journal of Prevention of Alzheimer’s Disease. It includes:
- How to choose appropriate patients: Patients should have mild cognitive impairment due to Alzheimer’s, mild Alzheimer’s dementia and the presence of brain amyloid confirmed by using amyloid positron tomography or cerebrospinal fluid findings.
- Ways to safely scale up to the full dose: Aducanumab is titrated to a dose of 10 mg/kg over a six-month period. The authors recommend that aducanumab be titrated to the highest dose to maximize the opportunity for efficacy.
- How to monitor side effects: Since aducanumab can substantially increase the incidence of amyloid-related imaging abnormalities brain bleeds or hemorrhage, the panel recommends MRIs before and during the titration of the drug, and at any time the patient has symptoms of these problems.
- Best practices in assessing effectiveness.
- When to stop therapy.
- Which patients should not receive the drug.
Patient and caregiver engagement before and during treatment is of critical importance, the authors added. This should include comprehensive discussions and clear communication about therapy requirements, expected outcomes, and potential risks and side effects. Patients and their caregivers should also be aware of the required safety monitoring needed, and “uncertainties regarding individual responses and benefits,” the authors said.
The recommendations also address a variety of other best-practices topics, among them:
- Guidance on the use of other Alzheimer’s drugs in combination with aducanumab;
- The potential impact of neurological, medical and psychiatric illnesses on the use (and non-use) of the treatment;
- Use of aducanumab in patients with moderate or severe Alzheimer’s, atypical Alzheimer’s, and non-Alzheimer’s amyloid-bearing conditions; and
- Special efforts required to engage minority patients and to communicate the need for care and the opportunities for treatment.