Promising Data Presented for Investigational Oral Treatment for People with Alzheimer’s

Once-daily treatment with tazbentetol (SPG302; Spinogenix, Los Angeles, CA) was associated with rapid and sustained improvements in cognitive and functional measures in a study of adults with mild-to-moderate Alzheimer disease (AD), according to topline results presented at the 18th annual Clinical Trials on Alzheimer’s Disease (CTAD) conference. The company also reported a favorable safety profile with no severe or treatment-related adverse events. Tazbentetol is an orally administered pill under investigation for the treatment of people with AD, amyotrophic lateral sclerosis (ALS), and schizophrenia and is designed to regenerate synapses lost in neurodegenerative and neuropsychiatric conditions.

In the 24-week, randomized, double-blind, phase 2a clinical trial (NCT06427668) conducted in Australia, 24 individuals with mild-to-moderate AD received treatment with tazbentetol (150 mg or 300 mg), with a 4-week placebo-controlled period, followed by an open-label phase. Primary end points included changes in Standardized Mini-Mental State Examination (SMMSE), Clinical Dementia Rating Sum of Boxes (CDR-SB), Alzheimer’s Disease Cooperative Study–Activites of Daily Living (ADCS-ADL), and EEG biomarkers of brain activity associated with AD. After the 24-week trial period, participants had the option to remain on open-label tazbentetol 300 mg once daily for up to 52 additional weeks. 

Key findings reported for the 300-mg dose included the following:

• Participants receiving tazbentetol 300 mg demonstrated an average increase in SMMSE of >2.5 points within 4 weeks compared with placebo (P<.05).
• Cognitive and functional improvements assessed by SMMSE, CDR-SB, and ADCS-ADL scores were sustained over the 24-week open-label period.
• Participants’ scores on the CDR-SB and ADCS-ADL scales continued to improve over time from baseline through 40 weeks of treatment.
• EEG analyses showed significant changes in AD-related brain activity, including reversal of established cortical “slowing” metrics across multiple frequency bands.
• Tazbentetol showed a favorable safety profile, with no severe or treatment-related adverse events and good tolerability as monotherapy and in combination with standard-of-care AD therapies.

Source: Spinogenix. Spinogenix reports evidence of rapid, sustained cognitive improvement in Alzheimer’s patients from phase 2a trial of tazbentetol (formerly SPG302). PR Newswire. Published 8 December, 2025. Accessed 10 December, 2025. https://www.prnewswire.com/news-releases/spinogenix-reports-evidence-of-rapid-sustained-cognitive-improvement-in-alzheimers-patients-from-phase-2a-trial-of-tazbentetol-formerly-spg302-302635266.html