On 7 July, the National Task Group on Intellectual Disabilities and Dementia Practice (NTG) published a consensus statement on issues related to Down Syndrome and aducanumab. NTG is a US-based, not-for-profit organisation advocating for people with intellectual disability and their families who are affected by Alzheimer's disease and dementias.
The NTG statement was co-developed with a panel of experts following on from the approval of aducanumab by the US Food and Drug Administration (FDA) on 7 June, via its Accelerated Approval pathway. In their consensus statement, which has also been endorsed by several organisations and patient associations, the NTG underlines the fact that Down Syndrome (DS) is a noted risk factor for early-onset Alzheimer's disease (AD), with an estimated 90% lifetime risk of developing the disease. Recent studies indicate that people with DS who develop AD often have high levels of amyloid plaques in their brains, similar to neurotypical people who develop AD - and the population of people with mild cognitive impairment (MCI) or mild AD who participated in the aducanumab clinical trials.
In their statement, the NTG draws attention to important issues with the aducanumab trials and FDA approval for people with DS, notably a lack of data on applicability of anti-amyloid drugs for people with DS, absence of protocols for use, and the unknown efficacy of aducanumab in people with a high brain amyloid load from early age. To address these and other issues, the NTG and co-signatories of the statement call for participants with DS to be included in ongoing and additional clinical trials for aducanumab; the development of protocols for assessment and decision-making in relation to people with DS and aducanumab; systematic screening for early symptoms of AD in people with DS and/or intellectual disabilities; and the involvement of the adult with DS, their families and caregivers in the decision-making process.The full statement can be accessed via the NTG website, here: