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IGC-AD1 Trial on Agitation in Dementia Due to Alzheimer's (IGC-AD1-P2)

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ClinicalTrials.gov Identifier: NCT05543681
Recruitment Status : Recruiting
First Posted : September 16, 2022
Last Update Posted : January 8, 2024
Sponsor:
Information provided by (Responsible Party):
India Globalization Capital Inc ( IGC Pharma LLC )

Tracking Information
First Submitted Date  ICMJE September 14, 2022
First Posted Date  ICMJE September 16, 2022
Last Update Posted Date January 8, 2024
Actual Study Start Date  ICMJE October 11, 2022
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2022)
Agitation [ Time Frame: Baseline to week six ]
Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2022)
Change in mean CMAI between baseline and EOT. [ Time Frame: Six weeks ]
To assess the efficacy of IGC-AD1 in Participants with symptomatological Agitation associated with mild to severe dementia due to AD, in a six-week, placebo-controlled trial, using the CMAI.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2022)
Acute Agitation [ Time Frame: Baseline to week two ]
Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2022)
Change in mean CMAI between baseline and week two. [ Time Frame: two weeks ]
To assess acute efficacy of IGC-AD1 on symptomatological Agitation, in dementia due to AD, in a two-week placebo-controlled trial using CMAI.
Current Other Pre-specified Outcome Measures
 (submitted: September 29, 2022)
  • Agitation at week four [ Time Frame: Baseline to week four ]
    Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
  • Participant overall wellbeing [ Time Frame: Baseline to weeks two and six ]
    Change in the Clinical Global Impression Scale (CGI)
  • Participant executive functions [ Time Frame: Baseline to week six ]
    Change in Mini-Mental State Examination (MMSE2) score
  • Depression [ Time Frame: Baseline to weeks two, four, and six ]
    Change in mean Cornell Scale for Depression in Dementia (CSDD) score
  • Neuropsychiatric symptoms [ Time Frame: Baseline to weeks two, four, and six ]
    Change in mean Neuropsychiatric Inventory (NPI-12) score
  • Participant quality of life [ Time Frame: Baseline to weeks two, four and six ]
    Change in mean Quality of Life in Alzheimer's Disease (QOL-AD) score
  • Caregiver burden [ Time Frame: Baseline to weeks two and six ]
    Change in mean Zarit Burden Interview (ZBI) score
  • Psychotropic drugs [ Time Frame: Baseline to six weeks ]
    Change in type and dosage of psychotropic drugs
  • CYP2C9 polymorphisms on agitation [ Time Frame: 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.)
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IGC-AD1 Trial on Agitation in Dementia Due to Alzheimer's
Official Title  ICMJE A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Trial of the Safety and Efficacy of IGC-AD1 on Agitation in Participants With Dementia Due to Alzheimer's Disease
Brief Summary The purpose of this study is to assess the efficacy of an oral medication, IGC-AD1 that is a natural THC-based (Tetrahydrocannabinol) formulation, administered in micro doses, twice a day, on symptomatological Agitation, in patients with mild to severe dementia from Alzheimer's.
Detailed Description

This is a placebo-controlled, multi-site, parallel, double blind, randomized study. Enrollment is open for Participants ages 60 and above with mild to severe dementia due to Alzheimer's Disease, with established symptomatological Agitation, for a minimum of two weeks prior to enrollment, with Agitation due to other etiologies, or recent, or transient Agitation symptoms ruled out. Clinical Agitation is established with a baseline NPI-12 (Agitation Domain only) score ≥ 4 as well as meeting the IPA criteria for Agitation.

The medication is titrated to BID over two days and down over two days at End of Trial (EOT). Caregivers will monitor and record in a logbook vitals daily using Sponsor provided scales and logbook.

Safety will be monitored with daily calls to the Participant/Caregiver dyad for the first four days followed by calls every third day till EOT. Week two is an on-site visit with week-four being optional.

Both solicited AEs and non-solicited AEs will be monitored, assessed, graded, and tabulated. Solicited AEs include the following: somnolence, falls, dizziness, asthenia, nausea, suicidal ideation, tachycardia, bradycardia, hypertension and hypotension, and BMI.

The primary objective of the study is to assess the efficacy of IGC-AD1 on Agitation as scored by the CMAI between baseline and EOT with the secondary objective being acute efficacy as measured by the CMAI between baseline and week two. There are several exploratory objectives included elsewhere. The trial will also have blood draws for sparse Pharmacokinetics (PK).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multi-site, Randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to severe dementia from Alzheimer's and symptomatological Agitation.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-blind for study site and participants
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer Disease
  • Agitation,Psychomotor
  • Depression
  • Anxiety
  • Memory Impairment
  • Care Giving Burden
  • NPS
  • Agitated; State, Acute Reaction to Stress
  • Aggression
  • Aggressive Outburst
Intervention  ICMJE
  • Drug: Agitation management in Alzheimer's disease (IGC-AD1-Active)
    A non-sterile solution for oral administration.
    Other Names:
    • Active Study Drug
    • Study Drug
    • Active
    • IGC-AD1 Active
  • Drug: Agitation management in Alzheimer's disease (IGC-AD1-Placebo)
    A non-sterile solution for oral administration similar in color and texture to the Active.
    Other Names:
    • IGC-AD1 Placebo
    • Non-active study drug
    • IGC-AD1 Non-Active
    • Placebo
Study Arms  ICMJE
  • Active Comparator: Active Comparator: IGC-AD1Active
    IGC-AD1 Active Treatment THC plus another API plus excipients.
    Intervention: Drug: Agitation management in Alzheimer's disease (IGC-AD1-Active)
  • Placebo Comparator: Placebo Comparator: IGC-AD1 Placebo
    IGC-AD1 Placebo, similar to Active in color, taste, and texture, with excipients but without APIs.
    Intervention: Drug: Agitation management in Alzheimer's disease (IGC-AD1-Placebo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2022)
164
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2025
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 3 months 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): THC, melatonin, honey, curcumin, ethyl alcohol, vitamin-E TPGS, ascorbic acid, water, tween-80, and rutin.
  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 3 months 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Evelyn Gutierrez 3013394270 egutierrez@igcpharma.com
Contact: Ram Mukunda, MS 3015294996 ram@igcpharma.com
Listed Location Countries  ICMJE Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05543681
Other Study ID Numbers  ICMJE IGC-AD1-P2 BIDAG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party India Globalization Capital Inc ( IGC Pharma LLC )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE IGC Pharma LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dr. Saadia Shahnawaz, MD IGC Pharma LLC
PRS Account India Globalization Capital Inc
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP