Topic Reads: Current medications for dementia

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This page gives some excerpts and links for current medical treatments available for dementia.

Many medical conditions can create dementia symptoms. Research focus is mainly on Alzheimer’s Disease, the commonest form of dementia. There is no cure even for Alzheimer’s Disease.

Till May 2021, there was no approved disease-modifying medicine for Alzheimer’s Disease, and available drugs were symptomatic, focused on symptoms relief. A disease modifying drug targets the underlying pathophysiology of a disease to get a more enduring clinical benefit. Symptomatic drugs aim to relieve symptoms but do not target the underlying pathophysiology of the disease.

In June 2021, the FDA (Federal Drug Agency of USA) used an Accelerated Approval pathway to approve Aduhelm (aducanumab) (from BioGen) to treat patients with Alzheimer’s disease, the first novel therapy approved for Alzheimer’s disease since 2003[1]. This pathway requires the company to verify clinical benefit in a post-approval trial (to be completed by 2030). If the sponsor cannot verify clinical benefit, the FDA may withdraw approval of the drug[2]. Aduhelm is directed at reducing amyloid beta plaques in the brain. These plaques are a hallmark finding in the brain of patients with Alzheimer’s, and FDA expects that this reduction in the surrogate will lead to a reduction in the clinical decline.

Aduhelm is expected to be of benefit in the MCI/ early stages of AD. It has not been tested for patients in later stages of AD. While the approval is seen as a landmark that opens the way to more research and brings hope, the drug poses challenges and there has been controversy around the data from the studies and its effectiveness etc. Whereas some see it as a sign of hope and the Alzheimer’s Association has lobbied for it, some experts are skeptical and opposing the approval which they feel ignores the scientific evidence. [1,2,3,4,5,6,7] There was also a Congressional investigation into the approval, which, in Dec 2022, was critical of the approval and raised many concerns. [8, 9]

On January 6, 2023, the FDA (Federal Drug Agency of USA) used an Accelerated Approval pathway to approve Leqembi (lecanemab-irmb) (from Eisai) to treat patients with Alzheimer’s disease. Like Aduhelm, this is positioned as a disease-modifying drug for MCI/ early AD, is very expensive, requires administration using IV, and requires caution regarding side-effects, such as ARIA.[10,11,12,13]

Both these drugs are yet to be approved or made available in India . They are also extremely expensive (several lakhs of rupees a year) and require careful evaluation for being prescribed along with good follow-up to titrate the dose up to more effective dose levels and to watch out for side-effects.

Other than Aduhelm and Leqembi, there are no disease-modifying medicines for dementia, and these are not yet approved in India, so there is no disease-modifying medicine in India.

Additionally the 2023 Facts and Figures report of Alzheimer’s Association, USA mentions the drugs approved for use in the USA. As the excerpts with explanations below show (confirmed March 2023), the two approved drugs that may alter the biology of the disease are aducanumab and lecanumab which have limited applicability and are anyway unavailable in India [14].

Five of these drugs — donepezil, rivastigmine, galantamine, memantine and memantine combined with donepezil — are aimed at improving symptoms. They do not affect the underlying brain
changes that cause symptoms, nor do they alter the course of the disease…….

Two of the FDA-approved drugs — aducanumab and lecanemab — are aimed at changing the underlying biology of the disease. They remove beta-amyloid from the brain and slow cognitive and functional decline in people living with early Alzheimer’s. They are not cures for Alzheimer’s disease and not appropriate for all
individuals living with Alzheimer’s disease….

The National Institute on Aging has a page discussing treatment[15] that explains that the medical approach still has a long way to go. While this page discusses Aducanumab (Aduhelm), it does not yet have (as of March 2023) information on lecanemab. Some sections of the page (reconfirmed March 2023) remain relevant in India where this new drug is not available:

Alzheimer’s disease is complex, and it is therefore unlikely that any one drug or other intervention will ever successfully treat it in all people living with the disease…..
…
Most medicines work best for people in the early or middle stages of Alzheimer’s. However, it is important to understand that none of the medications available at this time will cure Alzheimer’s.

Links to some standard, authoritative sources are provided in the reference section below for further reading.

Note that some private clinics and organizations push their “stem cell therapy” product as a sure way to cure Alzheimer’s and other dementia. This is misleading. The Indian Govt. has issued guidelines on stem cell research[16]. It has also cautioned against untested techniques and the harms to patients by laboratory manipulation of stem cells[17]. The Indian Medical Association considers using bone marrow and cord blood stem cells for anything other than therapy for blood disorders as malpractice[18]. Also, while stem cell research is an important direction of research for Alzheimer’s Disease, there is no approved treatment yet. The position of the Alzheimer’s Society on Stem Cell Research/ Therapies is available online [19].

A related topic is the effectiveness of alternate therapies. Many media reports claim that some activities or some herbs or foods can prevent or cure dementia. Various claims and reports are discussed on our page here[20], which also talks about how to interpret studies and evaluate alternate therapies.

References from above discussion

Additional links to understand the status of treatments and research:

This topic read page is referred to from: Diagnosis, Treatment, Prevention.

[The information on this page is a collation from standard, authoritative sources, provided only for convenience. Caregivers can check out these and other sources to get better informed about this topic.]

Dementia Care Notes