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Pharmaceuticals
Miscellaneous Drug Information
The NTG has put together this compilation of materials related to pharmaceuticals, including publications regarding clinical trials for pending therapeutics and information on newly approved therapeutics for Alzheimer's disease, and advisories related to the medications in use as applicable to adults with dementia, and cautions about over-medication and medication harm that might heighten risk for cognitive impairment. While this information is not prescriptive it is included to offer a one-stop source of information.
For more information on specifics for the currently FDA approved medications for Alzheimer's disease click on the buttons to the right. See also the news items on the far right below.
News Worthy Items on Alzheimer's Disease Treatment Medications
News on Kisunla (donanemab) and Intellectual Disability
Donanemab, a drug for Alzheimer's disease received unanimous approval, on June 10, 2024, from a panel of scientists advising the US Food and Drug Administration (FDA), bringing the treatment a step closer for use with the general population. On July 2, 2024, the drug, now labelled as Kisunla, was approved for use in the United States by the FDA. Although clinical trials' participants did not include any adults with intellectual disability it is expected that the treatment could offer equal benefit to this population. As with Leqembi, experts caution about its use with adults with Down syndrome until safety considerations are resolved. Such concerns have not been raised with respect to adults with other etiologies of intellectual disability. Now, with full FDA approval, it is anticipated that the clinical community will weight in on any unanticipated concerns for use with persons with intellectual disability. With respect to its use with adults with Down syndrome, the drug's developer, Eli Lilly, has announced that it will undertake a clinic trial of its use with this group of adults in the near future.
NTG Advisory on Over-Medication
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The National Task Group and the Health Matters Program at the University of Illinois Chicago collaborated on an advisory on over-medication of persons with intellectual disability. The organizations are part of the Centers for Disease Control and Prevention’s (CDC) Healthy Brain Initiative. The Health Matters Program produces materials related to encouraging healthy lifestyle among persons with intellectual disability as its contribution to the CDC’s Healthy Brain Initiative.
The National Institute on Aging and other organizations have noted that too often there is an accumulation of medications taken by older adults, and some of these medications may be no longer necessary or result in adverse effects. Studies show that many adults with intellectual disability are on numerous medications over their lifetime. Among older adults, some of these medications are still being taken even if unnecessary, others taken may cause behavioral problems or adverse health effects. Some taken for long periods may lead to cognitive problems and possibly dementia.
“This is a much-needed advisory,” said Dr. Seth Keller, a neurologist and co-president of the National Task Group and the past-chair of the American Academy of Neurology's Section on Adults with Intellectual Disability, "as research and medical practice shows that many adults with intellectual disability may be on too many inappropriate medications.” Many families are concerned that some medications taken may have lost their original purpose or may be interfering with everyday functioning. Too often medication reviews are not undertaken and persons with intellectual disability, their families, and others concerned about their welfare, are not informed about how the medication being prescribed may not long be needed.
The new advisory, "Over-Medication and Older Adults with Intellectual Disability: Risks for Brain Health," cautions users and families about several issues that arise from over-prescription and over-medication. It offers suggestions for actions that primary care practitioners may undertake to review medications and their impact, as well as what families may do to become better informed and request medication reviews.
Development of this advisory was supported by a grant from the Centers for Disease Control and Prevention (CDC), National Center for Chronic Disease Prevention and Health Promotion, The Healthy Brain Initiative Award #1 NU58DP006782-01-00 to the University of Illinois Chicago. Contents are solely the responsibility of the authors and do not represent the official views of the CDC.
Over-Medication and Older Adults with Intellectual Disability: Risks for Brain Health
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Click to access HCBS.org
Publications of Interest on Medications
Publications of Interest
Pharmaceutical News
Access to New Alzheimer's Therapeutics
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NTG and LuMind IDSC Foundation Collective Effort to Create
Equivalency in Criteria Used to Determine Access to FDA Approved Alzheimer's Disease Modifying Therapeutics
At issue is that States current eligibility criteria for accessing newly authorized, by the Food and Drug Administration (FDA), Alzheimer's therapeutics for use with the general population are not appropriate for individuals with Down syndrome who are living with the disease. The criteria for patients with Late Onset Alzheimer’s Disease (LOAD) focus on age, exclusion of non-Alzheimer’s causes for dementia, demonstrated cognitive impairment due to mild cognitive impairment or mild Alzheimer's disease, and biomarker indicators of amyloid plaques presence.
Instruments recommended to identify dementia in the LOAD population may not sufficiently be sensitive to accurately detect early stages of the disease in individuals with Down syndrome and other criteria also need to be adapted for adults with Down syndrome. The purpose of this effort to formulate a statement that can serve as a guide for determining equivalent eligibility for adults with Down syndrome (as well as for adults with other intellectual disability) by offering alternative measures, criteria, and processes
An international experts working group was assembled and asked to define the equivalencies for instruments used with the general population, but inappropriate for use with persons with lifelong intellectual disability. The group began its work in February 2023 and completed its recommendations in May 2023. It's report has been distributed to various stakeholders, including the FDA, CMS, and state Medicaid directors. To read the report.
Postscript
In July 2033, the FDA gave traditional approval to the second such anti-amyloid mediation, Leqembi, for use with sporadic Alzheimer’s disease among adults diagnosed with mild cognitive impairment and early-stage Alzheimer’s dementia. Also, in July 2023, the Center for Medicaid and Medicate Services issued a policy notice that Medicare would cover the use of the DMTs, if the prescriber and patient were entered into an approved registry. In reviewing the protocol, the NTG/LuMind team noted that select items (linked to the ‘problems’ noted above) were also found in the registry protocol. A meeting was held by the NTG/LuMind principals and senior CMS officials to attempt to rectify the issues noted above. CMS agreed to review the items in the registry protocol to permit accommodating data from adults with Down syndrome; the team was asked to submit specific language recommendations. The team has now gone back to the expert panel for its recommendations in wording with reference to specific instruments and processes. The effort is now pending follow-up with the expert panel.
Publications
A manuscript ("Adapting Eligibility Criteria for Prescribing FDA Approved Amyloid Targeted Immunotherapeutics for Adults with Down Syndrome with Early-Stage Alzheimer’s Disease"), describing the process and recommendations, has been prepared and is pending submission to a professional journal. A popularized summary of the issue and process, "Equitable Access to Alzheimer’s Disease Therapeutics for Adults with Down Syndrome" has been published in the September 2023 issue of HELEN: The Journal of Human Exceptionality.
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