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Oracle Runs

Oracle findings and outcome history for Clinical Trial on Agitation in Alzheimer's Dementia (NCT05543681).

Runs
3
Findings
3
Latest Run
Apr 6, 2026, 2:10 PM
Resolution Evidence
Outcome
YES
Status
Resolved
Settlement Date
4/6/26 UTC
Executive Summary

Interim analysis of this exact Phase 2 trial (NCT05543681) reported statistically significant CMAI reduction in agitation (p=0.037, effect size 0.66) vs placebo; sponsor explicitly framed as positive.

Sources
Sponsorigcpharma.com3/20/24
IGC Pharma Announces Positive Interim Results for IGC-AD1 in Reducing Alzheimer’s Agitation

Interim data demonstrates a clinical and statistically significant reduction in agitation compared to placebo... CMAI LS mean difference -10.45, p=0.037, Cohen’s d 0.66 at primary outcome.

View source
All Oracle Findings

Every stored oracle finding for this trial, including pending, dismissed, rejected, superseded, and accepted items.

YESAccepted75% confidenceGrok 4.20 (xAI)

Will the results be positive?

Interim analysis of this exact Phase 2 trial (NCT05543681) reported statistically significant CMAI reduction in agitation (p=0.037, effect size 0.66) vs placebo; sponsor explicitly framed as positive.

Found Apr 6, 2026, 2:10 PMReviewed Apr 6, 2026, 2:26 PM
Sponsorigcpharma.comMar 20, 2024, 12:00 AM
IGC Pharma Announces Positive Interim Results for IGC-AD1 in Reducing Alzheimer’s Agitation
Interim data demonstrates a clinical and statistically significant reduction in agitation compared to placebo... CMAI LS mean difference -10.45, p=0.037, Cohen’s d 0.66 at primary outcome.
NO_DECISIONDismissed90% confidencemanual-chat-review

Will the results be positive?

ClinicalTrials.gov still lists this study as recruiting with no posted results, so there is not yet a clear public positive or negative trial readout.

Found Apr 4, 2026, 8:54 PMReviewed Apr 4, 2026, 10:32 PM
ClinicalTrialsclinicaltrials.govJan 23, 2026, 12:00 AM
Study Details | NCT05543681 | ClinicalTrials.gov
ClinicalTrials.gov lists recruiting; primary completion 2026-03-30; hasResults=false on the latest posted update.
NO_DECISIONDismissed94% confidenceGPT-5.4 (OpenAI)

Will the results be positive?

No overall Phase 2 public readout is available yet for NCT05543681. The only trial-specific efficacy signal found is a sponsor-labeled positive interim analysis, but the trial was still ongoing in March 2026 and the sponsor said it was still moving toward full enrollment/readout. That is insufficient for an overall positive/negative call.

Found Apr 1, 2026, 7:55 PMReviewed Apr 1, 2026, 7:55 PM
Sponsorinvestor.igcpharma.comMar 20, 2024, 12:00 AM
IGC Pharma Announces Positive Interim Results for IGC-AD1 in Reducing Alzheimer’s Agitation
Sponsor reported positive interim Phase 2 data for NCT05543681, but noted the analysis was from a small subset (n=26) and said there was no guarantee the positive interim results would hold as enrollment continued.
Sponsorigcpharma.comMar 19, 2026, 12:00 AM
IGC Pharma Reports Financial Results and Clinical Progress for the Period Ended December 31, 2025
On March 19, 2026, IGC said CALMA had surpassed 70% enrollment and was moving toward full enrollment and a defined clinical readout; it also listed finalizing enrollment and preparing for the subsequent readout as upcoming catalysts.
Web Searchfdaaa.trialstracker.net
NCT05543681: An ongoing trial by IGC Pharma LLC
FDAAA TrialTracker lists NCT05543681 as ongoing, with Results Status: Ongoing and Actual reporting date: None, indicating no posted overall results readout yet.
Outcome History

Public history of accepted oracle reviews and recorded outcome changes for this trial.

Accepted Oracle ReviewApr 6, 2026, 2:26 PM

Will the results be positive?

PendingtoYEScurrentYES
Grok 4.20 (xAI)75% confidenceReviewed Apr 6, 2026, 2:26 PM

Interim analysis of this exact Phase 2 trial (NCT05543681) reported statistically significant CMAI reduction in agitation (p=0.037, effect size 0.66) vs placebo; sponsor explicitly framed as positive.