We may not fully understand the link between Covid-19 and Alzheimer’s, but we already have the scientific research and tools to address people’s fears, support their cognitive health journey, and reverse the increase of Alzheimer’s.

Alzheimer’s disease patients in the earliest stages of their disease benefited the most from Eli Lilly drug donanemab, which is expected to receive an FDA decision by the end of 2023. Full results from the drug’s pivotal study were presented during the during the Alzheimer’s Association International Conference.

As more life-extending medications come on the market, health systems have a responsibility to make meaningful changes in how they screen and reach older adults. Earlier detection could mean millions of individuals enjoy longer lives of good cognitive health.

Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval. While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks.

Medicare will cover Alzheimer’s disease drugs granted traditional FDA approval, CMS announced. But the decision keeps the spirit of an earlier coverage determination, which called for the gathering of more evidence about the safety and efficacy of these therapies.

Rexulti, a drug for schizophrenia and depression, now has an additional approval for treating agitation in Alzheimer’s disease patients. The FDA decision makes the Otsuka Pharmaceutical and Lundbeck product the first drug approved for this indication.

Patients treated with Eli Lilly Alzheimer’s disease drug donanemab showed a 35% slowing in decline compared to those given a placebo. Based on the Phase 3 results, Lilly said it would seek FDA approval for the drug by the end of June.

Merck, Sanofi, and Eli Lilly joined the Series A financing of Therini Bio, a startup developing a drug that selectively targets fibrin as a way of reducing disease-driving inflammation in neurodegeneration and eye disorders such as diabetic macular edema. Therini is preparing to advance its lead program to clinical testing.

The new year always brings hope, but this January that hope was palpable for the […]

Alzheimer’s disease research at MIT spawned Cognito Therapeutics, a startup whose medical device uses light and sound to modulate electrical activity that supports brain health. The company’s Series B financing will support a Phase 3 test of its technology in patients with mild-to-moderate disease.

Leqembi, the Eisai Alzheimer’s disease drug awarded accelerated FDA approval in January, could receive a decision on full approval in early July. But in setting the target date for a regulatory decision, the agency also said it plans to convene an advisory committee meeting to discuss the drug.

Eli Lilly’s accelerated approval application for its Alzheimer’s disease drug has fallen short. The company said the FDA is asking for data from more patients—results that must come from a larger study that’s underway but won’t report data until later this year.

A budget estimate attached to proposed legislation in Montana raises questions about whether the state’s cash-strapped communities will have the capacity to care for patients with Alzheimer’s disease, other types of dementia or traumatic brain injuries by July 2025, when involuntary commitments would cease under the plan.

Eisai Alzheimer’s disease drug Leqembi is now approved for the treatment of patients with an early form of the memory-robbing disease. In granting the antibody accelerated approval, the FDA employed reasoning that was the also basis for the controversial speedy regulatory nod for Biogen’s drug, Aduhelm.

Reducing hospitalizations for frail elderly members is a major challenge for Medicare Advantage payers and providers. The key to avoiding any hospitalization is to detect and address a change in condition before it worsens. Ceresti Co-founder and CEO Dirk Soenksen talks about how his company is addressing these needs.

Eisai has presented and published full data from the Phase 3 clinical trial for its Alzheimer’s disease drug lecanemab, with results showing a statistically significant slowing decline associated with the neurodegenerative disorder. While an accelerated approval decision is expected in early 2023, the latest trial data are key because they represent the confirmatory study that could support an application for full FDA approval.

There is a dearth of professionals with licenses and training to provide care for seniors’ mental and behavioral health challenges — such as Alzheimer’s and other dementias, anxiety and depression. Seattle-based Rippl Care is seeking to change this. The startup just closed a $32 million seed funding round led by ARCH Venture Partners and General Catalyst.

Eisai Alzheimer’s disease drug candidate lecanemab now has data from a pivotal study showing a statistically significant reduction in cognitive decline. Lecanemab is already under FDA review for potential accelerated approval but the agency has said that results from this larger study could support full approval of the antibody drug.

uMETHOD, which provides precision medicine software to treat cognitive decline, tapped at-home diagnostics provider Getlabs to supply mobile phlebotomies for its patients in Arizona. Blood tests are an essential part of the personalized care plans that uMETHOD provides, and the partnership seeks to make these tests accessible to patients with cognitive decline.

Value-based pricing could have shown us with more certainty the real level of effectiveness of Aduhelm. Maybe it is worth paying something for; and value-based contracts are the only way to figure that out.

Merck is paying $25 million to kick off a research partnership with Cerevance, a startup that analyzes donor brain tissue to find novel targets for new neurological disorder drugs. While Cerevance’s lead program is a Parkinson’s disease drug, Merck is wants to see if the startup’s technology can help it discover and develop new Alzheimer’s disease drugs.

Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. The regulator said that the data submitted were not from an adequate and well-controlled study and the company must run another clinical trial.

Memory Health CEO Edward Shehab talked about taking a preventive approach to neurodegenerative conditions.

AbbVie paid Alector $225 million up front five years ago to begin an R&D partnership on two drugs intended to bring an immunotherapy approach to the treatment of Alzheimer’s disease. One of the drugs has reached Phase 2 testing but the pharmaceutical giant has terminated the alliance on a program in Phase 1.

An Alzheimer’s disease drug from Athira Pharma has failed a Phase 2 clinical trial and the biotech has a surprising theory why. Athira says standard of care drugs Alzheimer’s patients are already taking may diminish the effect of its small molecule and this finding could inform how the company proceeds with an ongoing Phase 3 clinical trial.

The tests could prove useful in screening patients that coud benefit from therapies being tested for Alzheimer’s. But uptake will depend, in part, on reimbursement, according to doctors surveyed by Quest.

Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by a European Medicines Commission committee last December. The company was unable to persuade European regulators to change their minds about the drug.

New technologies for quantifying behavioral information and tracking neurological patterns have the potential to change treatment—but we must connect the data.

Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect of limiting use of the drug, but the agency said its decision provides clarity on what drug companies need to show in order to secure Medicare coverage.

AbbVie has acquired Syndesi Therapeutics, an early clinical neuroscience startup developing drugs that have potential applications in a range of cognitive disorders. Syndesi is based on research from Belgian pharmaceutical company UCB.