Also known as: Kisunla
Donanemab is a humanized monoclonal antibody marketed as Kisunla for Alzheimer's disease treatment in early symptomatic stages. It targets amyloid beta and is administered intravenously. The drug received U.S. approval in July 2024 and later EU authorization in 2025.
FDA approved a subcutaneous starting dose of Leqembi for early Alzheimer's disease. AAIC 2026 real-world data showed most patients stable or improved; a mouse study found KCL-286 repaired DNA damage and reduced inflammation.
A preclinical study shows that the anti-epileptic drug levetiracetam can prevent the formation of amyloid-beta 42 in neurons by modulating synaptic vesicle recycling. Analysis of patient records indicates a modest delay in cognitive decline among Alzheimer's patients taking the drug, suggesting potential for very early preventive use.
A review of more than 200 studies linked up to a third of dementia cases to diseases outside the brain. Trials and broader evidence also support multi-domain prevention strategies.
Alzheimer's blood tests are gaining FDA clearances and strong patient interest, yet surveys show clinicians remain skeptical about their reliability and clinical benefit. A UK survey found fewer than one-third of psychiatrists have used biomarkers, while only 6% of memory services meet access guidelines. An ethical framework urges careful implementation, especially in primary care.
A major evidence review of 17 clinical trials involving more than 20,000 participants found anti-amyloid Alzheimer’s drugs had absent or trivial effects on cognitive decline and dementia. The review also said the drugs likely increase the risk of brain swelling and bleeding.
A new Cochrane review said anti-amyloid Alzheimer’s drugs show no clinically meaningful benefit, but many researchers said the analysis has major limitations. Newer evidence on lecanemab and donanemab and broader drug development efforts continue to shape the field.
A review of 17 studies involving 20,342 patients found anti-amyloid Alzheimer’s drugs had “trivial” effects after 18 months and increased the risk of brain swelling and bleeding. A separate PET study suggested ARIA-E may mark brain regions with greater amyloid plaque reduction.
NICE has upheld appeals to review its guidance on Alzheimer's drugs lecanemab and donanemab, sending the decision back to committee. The manufacturers argued NICE failed to account for the treatments' wider impact on unpaid carers. This comes amid broader challenges in neurodegenerative disease research following recent high-profile clinical trial failures.
Eli Lilly's weight-loss drug Mounjaro fueled sevenfold sales growth in Brazil and doubled sales in India within months of launch, as the company commits $1 billion to make India a global export hub for its supply chain.
Blood-based biomarkers including brain-derived tau and amyloid-beta are enabling earlier Alzheimer's disease diagnosis through non-invasive testing, though confirmatory imaging remains necessary before treatment initiation.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07602582 |
A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT). |
RECRUITING | PHASE3 |
| NCT07589595 |
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7) |
RECRUITING | PHASE2 |
| NCT07571161 |
Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease |
RECRUITING | PHASE3 |
| NCT07167966 |
Alzheimer's Tau Platform: Regimen A - AADvac1 |
ENROLLING_BY_INVITATION | PHASE2 |
| NCT06996730 |
A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment of Autosomal-Dominant Alzheimer's Disease |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT06911944 |
Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation |
NOT_YET_RECRUITING | PHASE4 |
| NCT06566170 |
A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease |
RECRUITING | |
| NCT05738486 |
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05567159 |
A Study of Donanemab (LY3002813) in Healthy Participants |
COMPLETED | PHASE1 |
| NCT05533411 |
A Study of Donanemab (LY3002813) in Healthy Chinese Participants |
COMPLETED | PHASE1 |
