Something meaningful has shifted in the dementia treatment landscape, and it has shifted quickly. For decades, a diagnosis of Alzheimer's disease or related dementia came with a grim and consistent message: there are no therapies that change the course of this disease. That is no longer true. And the implications for how we approach early detection are more significant than many in the field have fully reckoned with.
A Pipeline That Has Turned a Corner
The numbers from Dr. Jeffrey Cummings' 2026 annual pipeline report, published in Alzheimer's and Dementia: Translational Research and Clinical Interventions, tell a story worth pausing on. There are now 158 drugs being evaluated across 192 active clinical trials worldwide. That represents a 35% increase in trials and a 40% increase in therapies being tested since 2016. Over the past year alone, 59 new trials entered the pipeline.
Cummings, who has tracked this data for a decade, put it plainly: "Alzheimer's is no longer an untreatable disease."
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158 drugs in 192 active clinical trials |
35% increase in trials since 2016 |
59 new trials entered the pipeline in the past year |
What's equally significant is how the pipeline has diversified. In 2016, roughly a third of all drugs in development targeted amyloid. Today that figure sits around 18 to 20%, while inflammation and immune-targeting agents have grown from 6% to 18% of the pipeline. Tau-directed therapies, synaptic plasticity agents, and metabolic and vascular pathway treatments are all advancing. The field has moved from a single dominant hypothesis toward a recognition that Alzheimer's is a complex, multifactorial disease that likely requires a range of approaches.
"It is clear that Alzheimer's is a complex disease with many contributing elements," Cummings noted. "Inflammation is consistently present in the brain of Alzheimer's patients, and reducing the inflammatory response promises to slow the disease process.
Findings from 29 Phase 2 trials are expected to read out in 2026 alone, meaning the next wave of evidence is already in motion.
FDA Approval as a Signal of What's Possible
Beyond the pipeline, two disease-modifying therapies have now received full FDA approval: lecanemab (Leqembi) in July 2023 and donanemab (Kisunla) in July 2024. These are not symptomatic treatments. They represent the first therapies approved to address the underlying biology of Alzheimer's disease and slow its progression.
Their approval matters not just for what they do, but for what they signal: that the regulatory pathway for disease-modifying Alzheimer's treatment is open, that the FDA has defined approvable outcomes, and that the clinical and scientific framework is now in place to support the next generation of therapies moving through the pipeline.
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For the first time, we have FDA-approved therapies that change the course of Alzheimer's disease. What comes next depends on our ability to find patients early enough to benefit. |
There is a critical condition attached to both approvals, however. Lecanemab and donanemab are indicated specifically for patients with mild cognitive impairment or early-stage Alzheimer's disease. They were not studied, and are not effective, in patients with moderate or advanced disease. The window for treatment is early, and it is defined.
Why Early Detection Is the Prerequisite for Everything Else
This is where the treatment story and the detection story converge, and where I believe the most important work in this field is happening right now.
A therapy that requires early-stage diagnosis to work is only as good as the system's ability to identify patients at that stage. And today, that system is not reliable enough. Up to 61% of people living with dementia remain undiagnosed. The vast majority of MCI cases go undetected in routine primary care. The traditional screening tools most clinicians have available were not designed to catch subtle, early-stage cognitive decline. They were designed to confirm impairment that is already clinically apparent.
That gap has always had human consequences. But with the arrival of approved disease-modifying therapies and a pipeline generating new candidates every year, it now has treatment consequences as well. Every patient who reaches a moderate stage of disease without a prior MCI diagnosis is a patient who may have been eligible for treatment and wasn't identified in time.
The math is straightforward: the more effective the treatments become, the more consequential early detection becomes. The two are inseparable.
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Early Detection as a Clinical Infrastructure Problem Both currently approved disease-modifying therapies for Alzheimer's disease require confirmed early-stage diagnosis for eligibility. As the pipeline matures and new therapies emerge across diverse biological targets, the ability to identify cognitive decline at the MCI stage will determine which patients can access them. Detection is not a preliminary step. It is the gateway to the entire treatment pathway. |
What "Earlier" Actually Requires
Identifying cognitive impairment early is not simply a matter of intent. It requires tools with the sensitivity to detect subtle functional decline before it becomes obvious, embedded in workflows where patients are already being seen.
Most older adults who have annual wellness visits are never cognitively screened at those visits. The standard tools in wide use take 10 to 20 minutes, require clinician scoring, and were validated on narrow populations decades ago. They don't fit the workflow, and for many patient populations, they don't generate reliable results.
Platforms like Neurotrack's Cognitive Care Enablement Platform are designed specifically for this gap: sensitive enough to catch decline at the MCI stage, fast enough to fit a wellness visit, integrated directly into the EHR, and connected to the care pathways that give detection its clinical meaning. Not just a screener, but the full infrastructure from identification through care planning and longitudinal monitoring.
As the treatment landscape continues to evolve, that infrastructure becomes increasingly central to the care of patients with Alzheimer's disease and dementia. The drugs are advancing. The science is delivering. The question now is whether the detection and care systems are ready to meet them.
The Window Is Defined. The System Has to Be Ready.
We are at an inflection point in dementia care. A decade of pipeline investment is producing results. The regulatory framework is in place. New therapeutic approaches are reading out. The field that once had no disease-modifying options for Alzheimer's disease now has two approved treatments and a robust pipeline of diverse candidates behind them.
What this moment requires, more than anything, is the ability to find patients early: identify those with genuine cognitive impairment at the MCI stage, connect them to care pathways, and prepare both patients and families for what comes next.
The treatments are arriving. Detection is how we make sure patients are ready for them.
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61% of people with dementia are undiagnosed. That's the gap the next generation of treatments depends on closing. |
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Ready to identify patients before the window closes? Neurotrack's Cognitive Care Enablement Platform gives health systems and Medicare Advantage plans the tools to detect cognitive decline at the MCI stage, document with clinical precision, and activate the care pathways that connect patients to treatment. neurotrack.com | Schedule a Demo |
Russ Banks, PhD, is Chief Science Officer at Neurotrack. Neurotrack's Cognitive Care Enablement Platform provides digital tools for early cognitive detection, longitudinal monitoring, and care pathway activation, built to identify patients at the MCI stage when treatment options are greatest.