Dementia Associated With Alzheimer's Disease - Pipeline Insight, 2025: Advancing Beyond Amyloid with Novel Mechanisms and Combination Strategies | DelveInsight

Dementia associated with Alzheimer's disease (AD) remains a high-burden neurodegenerative condition, with limited disease-modifying therapies approved to date. However, 2025 marks a turning point, as the R&D landscape shifts beyond amyloid-targeted drugs toward novel mechanisms, including tau aggregation inhibitors, neuroinflammation modulators, and synaptic enhancers.

DelveInsight's "Dementia Associated With Alzheimer's Disease - Pipeline Insight, 2025" provides a comprehensive overview of more than 100 assets in development. Key players such as BioVie, Karuna Therapeutics, Cassava Sciences, Inc., Cognition Therapeutics, Alector, TrueBinding, and others are exploring advanced modalities, including monoclonal antibodies, small molecules, and gene therapies. Particular focus is placed on agents targeting tau pathology, neuroinflammation, and neuronal regeneration pathways.

As amyloid beta-directed therapies face efficacy and access limitations, next-generation candidates are being evaluated in monotherapy and combination settings across various stages of cognitive impairment. The report covers registrational studies, FDA designations, and biomarker-driven approaches that aim to reshape the future of dementia treatment.

With growing patient advocacy, regulatory incentives, and a deeper understanding of AD pathophysiology, the pipeline is rapidly expanding, offering new hope for patients living with Alzheimer's-related dementia.

Interested in learning more about the current treatment landscape and the key drivers shaping the dementia associated with Alzheimer's disease pipeline? Click here: https://www.delveinsight.com/report-store/dementia-associated-with-alzheimers-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Dementia Associated With Alzheimer's Disease Pipeline Report
• DelveInsight's dementia associated with Alzheimer's disease pipeline analysis depicts a strong space with 80+ active players working to develop 100+ pipeline drugs for dementia associated with Alzheimer's disease treatment.
• The leading dementia associated with Alzheimer's disease companies include BioVie, Karuna Therapeutics, Cassava Sciences, Inc., Cognition Therapeutics, Alector, TrueBinding, KeyMed Biosciences, Alzinova, AriBio Co., Ltd., Eli Lilly & Co., AbbVie Inc., Allyx Therapeutics, Inc., Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., and others are evaluating their lead assets to improve the dementia associated with Alzheimer's disease treatment landscape.
• Key dementia associated with Alzheimer's disease pipeline therapies in various stages of development include NE3107, KarXT, Simufilam, CT-1812, AL002, TB 006, CM383, ALZ 101, AR1001, LY3372689, CT1812, ABBV-916, ALX-001, E2814, VT301, and others.
• In June 2025, Cognition Therapeutics (NASDAQ: CGTX) announced it will hold an end-of-Phase 2 meeting with the FDA on July 9 to review results from the Phase 2 SHINE study (NCT03507790) of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease and discuss plans for a Phase 3 trial to support regulatory approval.
• In March 2025, BioXcel Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has closed the inspection of a single site in its TRANQUILITY II Phase 3 trial under 21 C.F.R.20.64(d)(3) and released the Establishment Inspection Report.
• In January 2025, the FDA approved Amneal Pharmaceuticals' memantine/donepezil 14-10 mg and 28-10 mg extended-release capsules for the treatment of moderate to severe Alzheimer's dementia, along with everolimus tablets for oral suspension, and granted tentative approval for rifaximin oral tablets.
• In January 2025, BioArctic AB announced that the U.S. FDA has accepted Eisai's Biologics License Application (BLA) for the Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. Leqembi is indicated for the treatment of Alzheimer's disease in patients with Mild Cognitive Impairment (MCI) or mild dementia, referred to as early AD.

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Dementia Associated With Alzheimer's Disease Overview
Dementia associated with Alzheimer's disease is the most prevalent form of dementia, accounting for an estimated 60-80% of all cases globally. It is a progressive neurodegenerative disorder marked by the deterioration of memory, cognitive function, behavior, and the ability to perform daily activities. The condition stems primarily from the accumulation of beta-amyloid plaques and tau tangles in the brain, leading to neuronal loss and synaptic dysfunction.

Alzheimer's-related dementia typically begins with mild memory lapses and confusion, gradually progressing to severe impairment in reasoning, judgment, language, and mobility. As the disease advances, individuals require full-time care, placing a significant emotional and financial burden on families and caregivers. While age remains the most prominent risk factor, genetics, cardiovascular health, and lifestyle also influence disease onset and progression.

Currently, there is no cure for Alzheimer's disease. Approved treatments-including cholinesterase inhibitors and NMDA receptor antagonists-primarily offer symptomatic relief. However, recent approvals of amyloid-targeting monoclonal antibodies and emerging therapies aimed at tau pathology and neuroinflammation signal a shift toward disease-modifying strategies. Ongoing clinical research and innovation are now focused on slowing or halting cognitive decline, enhancing early diagnosis through biomarkers, and delivering more personalized treatment approaches for affected individuals.

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Dementia Associated With Alzheimer's Disease Treatment Analysis: Drug Profile
NE3107 - BioVie
NE3107 is an orally administered small molecule being developed by BioVie, with potential anti-inflammatory and insulin-sensitizing effects. Originally developed by NeurMedix and later acquired by BioVie, the compound is capable of crossing the blood-brain barrier. NE3107 works by selectively inhibiting two key regulators of inflammation-extracellular signal-regulated kinase (ERK) and nuclear factor kappa-light-chain-enhancer of activated B-cells (NF-κB). Both of these pathways are known to be activated by amyloid beta and tau proteins, which play a central role in the pathogenesis of Alzheimer's disease. NE3107 reduces neuroinflammation without suppressing beneficial physiological functions such as insulin signaling and neuronal growth. Importantly, the drug has shown no immunosuppressive effects. NE3107 is currently in Phase III clinical trials for the treatment of Alzheimer's disease.

AMX0035 - Amylyx Pharmaceuticals Inc.
AMX0035 is an investigational oral therapy developed by Amylyx Pharmaceuticals. It is a fixed-dose combination of sodium phenylbutyrate (PB) and taurursodiol (TURSO). The therapy targets two major drivers of neurodegeneration-endoplasmic reticulum (ER) stress and mitochondrial dysfunction. PB reduces ER stress by upregulating the chaperone regulator DJ-1, while TURSO supports mitochondrial integrity by integrating into the mitochondrial membrane and enhancing cellular resilience against apoptosis. Preclinical research has demonstrated the potential of AMX0035 to reduce neuronal death and improve cellular function, showing synergistic benefits over individual components. The drug is currently in Phase II development for Alzheimer's disease.

CT-1812 - Cognition Therapeutics
CT-1812 is an oral, brain-penetrant small molecule being developed by Cognition Therapeutics. It functions as a neuroprotective agent by preventing toxic amyloid beta oligomers from binding to synapses-a critical step in Alzheimer's pathology. By disrupting this binding, CT-1812 aims to protect neurons and preserve synaptic integrity, potentially slowing the progression of cognitive decline. The therapy is currently undergoing evaluation in Phase II clinical trials for the treatment of Alzheimer's disease.

Learn more about the novel and emerging dementia associated with Alzheimer's disease pipeline therapies at https://www.delveinsight.com/report-store/dementia-associated-with-alzheimers-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Dementia Associated With Alzheimer's Disease Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Dementia Associated With Alzheimer's Disease Pipeline Report
• Coverage: Global
• Key Dementia Associated With Alzheimer's Disease Companies: BioVie, Karuna Therapeutics, Cassava Sciences, Inc., Cognition Therapeutics, Alector, TrueBinding, KeyMed Biosciences, Alzinova, AriBio Co., Ltd., Eli Lilly & Co., AbbVie Inc., Allyx Therapeutics, Inc., Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., and others.
• Key Dementia Associated With Alzheimer's Disease Pipeline Therapies: NE3107, KarXT, Simufilam, CT-1812, AL002, TB 006, CM383, ALZ 101, AR1001, LY3372689, CT1812, ABBV-916, ALX-001, E2814, VT301, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Dementia Associated With Alzheimer's Disease Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Dementia Associated With Alzheimer's Disease Pipeline Therapeutics
6. Dementia Associated With Alzheimer's Disease Pipeline: Late-Stage Products (Phase III)
7. Dementia Associated With Alzheimer's Disease Pipeline: Mid-Stage Products (Phase II)
8. Dementia Associated With Alzheimer's Disease Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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