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IGC-AD1-forsøk på agitasjon ved demens på grunn av Alzheimers (CALMA)

28. september 2026 oppdatert av: IGC Pharma, LLC

En fase 2, multisenter, dobbeltblind, randomisert, placebokontrollert, utprøving av sikkerheten og effekten av IGC-AD1 på agitasjon hos deltakere med demens på grunn av Alzheimers sykdom

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

CALMA is a multi-center, double-blind, randomized, placebo-controlled clinical trial. The study targets participants aged 60 and older with mild to severe Alzheimer's dementia who have exhibited clinically significant agitation for at least two weeks prior to enrollment. Agitation caused by other conditions or transient symptoms must be ruled out. Eligibility is determined by a baseline Neuropsychiatric Inventory (NPI-12), Agitation subscale score of ≥4 and the International Psychogeriatric Association (IPA) criteria for agitation.

The investigational medication is an oral solution containing two active ingredients: delta-9 tetrahydrocannabinol (THC) and melatonin. The treatment is administered for 42 days, followed by a two-day taper period at the end of the study.

Safety oversight includes daily calls on days 2, 3, and 4, transitioning to calls every third day thereafter. These calls will review study partners logbook entries, changes in concomitant medications, and adverse events.

The primary objective of the study is to evaluate the efficacy of IGC-AD1 on agitation, measured by changes in the Cohen-Mansfield Agitation Inventory (CMAI) scores from baseline to the End of treatment (EOT). The secondary objective is to assess efficacy by examining CMAI score changes from baseline to week two. Additionally, exploratory objectives are outlined in separate documentation.

Blood samples will be collected during the trial for sparse pharmacokinetic (PK) analysis, blood-based CNS biomarker, and genotyping.

Studietype

Intervensjonell

Registrering (Antatt)

164

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Island Health Authorities
    • Ontario
      • Hamilton, Ontario, Canada, L8M 1W9
        • Hamilton Health Sciences , Mcmaster University
      • Toronto, Ontario, Canada, ON M6A 2E1
        • Baycrest Academy for Research and Education , University of Toronto
    • Quebec
      • Montreal, Quebec, Canada, H4H 1R3
        • Douglas Hospital Research Center, McGill university
  • Forente stater
    • Florida
      • Maitland, Florida, Forente stater, 32751
        • ClinCloud, LLC
      • Melbourne, Florida, Forente stater, 32940
        • ClinCloud, LLC
      • Miami, Florida, Forente stater, 33133
        • Visionary Investigators Network
      • Miami, Florida, Forente stater, 33137
        • Miami Jewish Health
      • Miami, Florida, Forente stater, 33125
        • Central Miami Medical Institute
      • Port Charlotte, Florida, Forente stater, 33952
        • Neurostudies Inc.
      • Tampa, Florida, Forente stater, 33613
        • University of South Florida Department of Psychiatry and Behavioral Neurosciences
    • Louisiana
      • Metairie, Louisiana, Forente stater, 70006
        • Tandem Clinical Research GI, LLC
    • Maryland
      • Baltimore, Maryland, Forente stater, 21237
        • MedStar Franklin Square Medical Center Neurology
      • Clinton, Maryland, Forente stater, 20735
        • Medstar Southern Maryland Hospital Center
      • Olney, Maryland, Forente stater, 20832
        • Medstar Montgomery Medical Center
    • Missouri
      • St Louis, Missouri, Forente stater, 63128
        • Tekton Research LLC
    • New York
      • Amherst, New York, Forente stater, 02459
        • Dent Neurologic Institute
      • Brooklyn, New York, Forente stater, 11229
        • Integrative Clinical Trials, LLC
      • Syracuse, New York, Forente stater, 13210
        • Ichor Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73112
        • Lynn Health Science Institute (LHSI)
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02906
        • Butler Hospital, Brown University
    • Texas
      • Austin, Texas, Forente stater, 78757
        • Senior Adults Specialty Research
      • Dallas, Texas, Forente stater, 75231
        • Kerwin Medical Center
      • Dallas, Texas, Forente stater, 75231
        • Baylor Scott and White Research Institute
    • Virginia
      • Richmond, Virginia, Forente stater, 23219
        • Dominion Medical Associates, Inc.
  • Puerto Rico
      • Bayamón, Puerto Rico, 00961
        • SCB Research Center Corp
      • Rio Piedras, Puerto Rico, 00935
        • The Alliance, Medical Sciences Campus University of Puerto Rico
    • Bayamón
      • Bayamón, Bayamón, Puerto Rico, 00961
        • Instituto Sanacoop

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

To be eligible to participate in this study, the participant must meet all the following criteria:

Inclusion Criteria

  1. Participant and/or Caregiver must provide a signed and dated ICF prior to any study procedures.

  2. Must have a Caregiver who is able and willing to comply with all required study procedures.

  3. The Caregiver must be known to the Participant and must be able to use electronic devices such as a cell phone, video conference over a laptop or cell phone, weighing scale, and be able to learn to take blood pressure, among others.

  4. Based on local practice, Participants that cannot consent may have Caregiver's consent provided the Caregiver has among others a) Power of Attorney, b) is a spouse, or c) a sibling or d) a child or e) a close relation. The practice of accepting consent must be consistent with established practice at the site and jurisdiction.

  5. Participants must consent to CYP450 and apolipoprotein E (ApoE) genotyping, and pharmacokinetics.

  6. Diagnosis of AD by NIA-AA criteria

  7. Clinically significant Agitation assessed by:

    1. NPI (Agitation) ≥ 4
    2. The presence of clinically significant, persistent Agitation based on the IPA definition (Appendix C) rather than those with recent onset and occasional symptoms, and
    3. Agitation not attributable to another psychiatric disorder, suboptimal care conditions, other underlining medical condition, or the physiological effects of a substance.

  8. Negative drug screen, except for benzodiazepines if Participant has been using them in stable doses for at least 3 months before screening.

  9. All medications used for behavioral symptoms should be consistent for at least 6 weeks before screening, with allowance for dose changes up to 25%.

  10. Women must be of no childbearing potential (postmenopausal, defined as cessation of menses for at least 12 months, without an alternative medical cause for amenorrhea) or surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation)).

An individual who meets any of the following criteria will be excluded from participation in this study:

Exclusion Criteria

  1. Prior adverse reaction to cannabinoids or to any component of Study Drug (IGC-AD1 and placebo).
  2. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease, which might confound assessment of safety outcomes.
  3. History of seizures, schizophrenia, or bipolar disorder.
  4. Has participated in an investigational drug or device study within 30 days prior to study start.
  5. Urine drug screen positive for drug use, except for benzodiazepines if Participant was using them previously and their dose had remained stable for at least six weeks before screening.
  6. History of Alcohol and Drug use disorder, within one year prior to enrollment.
  7. Hypertension: Participants with a history of uncontrolled hypertension as determined by the PI and Participants with a hypertensive crisis in the six months prior to enrollment.
  8. Falls: Participants with a history of recurrent falls defined as more than two falls in the six-month period prior to enrollment and a history of falls resulting in injuries or associated with a new acute illness, loss of consciousness, fever, or abnormal blood pressure (Fuller et al., 2000).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Active Comparator: IGC-AD1Active

IGC-AD1-Active, oral solution with two APIs (THC and melatonin).
Legemiddel: IGC-AD1-Active

A non-sterile solution for oral administration.

Andre navn:
  • Aktiv
Placebo komparator: Placebo Comparator: IGC-AD1 Placebo

IGC-AD1-Placebo, oral solution similar to Active in color, taste, and texture, with excipients but without APIs.
Legemiddel: IGC-AD1-Placebo

A non-sterile solution for oral administration similar in color and texture to the Active.

Andre navn:
  • Placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Agitation
Tidsramme: Baseline to week six

Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
Baseline to week six

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Acute Agitation
Tidsramme: Baseline to week two

Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
Baseline to week two

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Agitation at week four
Tidsramme: Baseline to week four

Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
Baseline to week four
Participant overall wellbeing
Tidsramme: Baseline to weeks two and six

Change in the Clinical Global Impression Scale (CGI)
Baseline to weeks two and six
Participant executive functions
Tidsramme: Baseline to week six

Change in Mini-Mental State Examination (MMSE2) score
Baseline to week six
Depression
Tidsramme: Baseline to weeks two, four, and six

Change in mean Cornell Scale for Depression in Dementia (CSDD) score
Baseline to weeks two, four, and six
Neuropsychiatric symptoms
Tidsramme: Baseline to weeks two, four, and six

Change in mean Neuropsychiatric Inventory (NPI-12) score
Baseline to weeks two, four, and six
Participant quality of life
Tidsramme: Baseline to weeks two, four and six

Change in mean Quality of Life in Alzheimer's Disease (QOL-AD) score
Baseline to weeks two, four and six
Caregiver burden
Tidsramme: Baseline to weeks two and six

Change in mean Zarit Burden Interview (ZBI) score
Baseline to weeks two and six
Psychotropic drugs
Tidsramme: Baseline to six weeks

Change in type and dosage of psychotropic drugs
Baseline to six weeks
CYP2C9 polymorphisms on agitation
Tidsramme: Baseline to weeks two, four and six

Change in mean Cohen Mansfield Agitation Inventory (CMAI) score for each type of metabolizer group (*1/*1, *1/*3, etc.)
Baseline to weeks two, four and six

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

IGC Pharma, LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. oktober 2022

Primær fullføring (Antatt)

1. november 2026

Studiet fullført (Antatt)

1. november 2026

Datoer for studieregistrering

Først innsendt

14. september 2022

Først innsendt som oppfylte QC-kriteriene

14. september 2022

Først lagt ut (Faktiske)

16. september 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IGC-AD1-P2 BIDAG

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

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