Clinical Trial on Agitation in Alzheimer's Dementia

Study acronym: CALMA
StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 2026 → Nov 2026
See other at-risk trials from IGC Pharma, LLC

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Primary and study completion pushed from Aug 2026 to Nov 2026
    • Trial sites reduced: 31 → 28 locations
    • Eligibility criteria expanded, about 21 words
  2. Study sites: 30 to 31v23
  3. Primary and study completion pushed from Mar 30, 2026 to Aug 2026
    • Study sites: 28 to 30
    v22
  4. Study sites: 27 to 28
    • Eligibility criteria shortened, about 14 words
    v21
  5. Study sites: 26 to 27v20
Show 18 earlier versionsHide 18 earlier versions
  1. Study sites: 24 to 26v19
  2. Primary and study completion dates: Jun 30, 2025 to Mar 30, 2026
    • Study sites: 22 to 24
    v18
  3. Study sites: 20 to 22v17
  4. Study sites revised (20)v16
  5. Study sites: 19 to 20v15
  6. Study title shortened, about 1 wordv14
  7. Interventions: Agitation management in Alzheimer's disease (IGC-AD1-Active) (Drug), Agitation management in Alzheimer's disease (IGC-AD1-Placebo) (Drug) to IGC-AD1-Active (Drug), IGC-AD1-Placebo (Drug)
    • Study title expanded, about 1 word
    v13
  8. Study sites: 13 to 19
    • Study description shortened, about 22 words
    • Study title shortened, about 2 words
    v12
  9. Study sites: 11 to 13v11
  10. Primary completion date: Mar 31, 2024 to Jun 30, 2025
    • Study sites: 10 to 11
    • Study completion date: Dec 31, 2024 to Jun 30, 2025
    • Eligibility criteria shortened, about 30 words
    v10
  11. Study sites: 5 to 10
    • Primary completion date: Dec 31, 2023 to Mar 31, 2024
    • Study completion date: Mar 30, 2024 to Dec 31, 2024
    v9
  12. Study sites: 4 to 5
    • Primary completion date: Aug 31, 2023 to Dec 31, 2023
    • Study completion date: Nov 30, 2023 to Mar 30, 2024
    v8
  13. Study sites: 3 to 4v7
  14. Study sites: 2 to 3
    • Interventions: Anti-agitation in Alzheimer's dementia (IGC-AD1-Active) (Drug), Anti-agitation in Alzheimer's dementia (IGC-AD1-Placebo) (Drug) to Agitation management in Alzheimer's disease (IGC-AD1-Active) (Drug), Agitation management in Alzheimer's disease (IGC-AD1-Placebo) (Drug)
    v6
  15. Re-verified, no change to tracked fieldsv5
  16. Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 1 to 2
    v4
  17. Start date changed from estimate of Oct 5, 2022 to Oct 11, 2022v3
  18. Primary endpoint revisedv2 Show 6 more changesShow less
    • Start date: Sep 26, 2022 to Oct 5, 2022
    • Interventions: IGC-AD1 (Drug) to Anti-agitation in Alzheimer's dementia (IGC-AD1-Active) (Drug), Anti-agitation in Alzheimer's dementia (IGC-AD1-Placebo) (Drug)
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoint revised
    • Study description shortened, about 441 words
    • Study title revised
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
IGC Pharma, LLC
1 trial monitored
See 1 trial at risk
Anxiety
3,284 trials monitored
See 154 trials at risk
Dementia
1,982 trials monitored
See 105 trials at risk
Alzheimer's Disease
1,255 trials monitored
See 68 trials at risk
The purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from Alzheimer's.
Trial Details
NCT Number NCT05543681
Lead Sponsor IGC Pharma, LLC
Conditions
(from sponsor)		 Alzheimer Disease, Agitation,Psychomotor, Care Giving Burden, NPS, Aggression
Related terms Aggression, Alzheimer Disease, Anxiety Disorders, Caregiver Burden, Dementia, Depression, Marijuana Abuse, Psychomotor Agitation
Enrollment 164 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov