KarX-EC / KarXT / Alzheimer's Disease · Phase 3 Trial

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

ClinicalTrials.gov · August 20, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 trial registration for KarXT + KarX-EC in Alzheimer's disease cognitive impairment, currently recruiting. No efficacy or safety results are posted in this registry record, and the study design and conduct details necessary to assess bias risk are not provided.

What was studied

Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Alzheimer's Disease; age from 60 Years; to 85 Years. Intervention: KarXT + KarX-EC. Compared with: Placebo — Placebo Comparator. n = 586. 119 sites across 19 countries.

Key findings

Safety

No efficacy or safety results are reported in this registry record

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 3 trial registration with no posted results; the study is actively recruiting and outcomes have not yet been reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) (assessed at At week 24); Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+) (assessed at At week 24)

DesignPhase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose

PopulationAlzheimer's Disease; age from 60 Years; to 85 Years

Sample size586

InterventionKarXT + KarX-EC

ComparatorPlacebo — Placebo Comparator

Setting119 sites across 19 countries

Reported figures

Quoted from the source exactly as published.

Planned sample size586

Primary endpoint 1Change from baseline in ADAS-Cog11 at week 24

Primary endpoint 2CIBIC+ at week 24

Study phasePhase 3

Caveats

No efficacy or safety results are reported in this registry record
Recruitment status is RECRUITING; study is ongoing and data are not final
Blinding, allocation concealment, and randomization methods are not described in this registry excerpt
Follow-up duration beyond week 24 primary timepoint is not specified in this record

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3 randomized controlled trial with placebo comparator

Directness

strong

Primary endpoints are cognitive assessment and clinician impression in Alzheimer's disease

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record

Risk of bias

insufficient

Registry record does not report blinding, allocation concealment, or conduct details

Sample adequacy

moderate

586 estimated participants planned; recruitment still ongoing

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06976216). This is a study registration, not published results. Lead sponsor: Bristol-Myers Squibb. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 586 participants (ESTIMATED). Conditions: Alzheimer's Disease. Interventions: DRUG: KarXT; DRUG: KarX-EC; OTHER: Placebo. Primary outcome measures: Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) , At week 24; Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+) , At week 24. Brief summary: The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

KarX-ECKarXTAlzheimer's DiseaseBristol-Myers SquibbNCT06976216