Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
164 participants
INTERVENTIONAL
2022-10-11
2026-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active Comparator: IGC-AD1Active
IGC-AD1-Active, oral solution with two APIs (THC and melatonin).
IGC-AD1-Active
A non-sterile solution for oral administration.
Placebo Comparator: IGC-AD1 Placebo
IGC-AD1-Placebo, oral solution similar to Active in color, taste, and texture, with excipients but without APIs.
IGC-AD1-Placebo
A non-sterile solution for oral administration similar in color and texture to the Active.
Interventions
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IGC-AD1-Active
A non-sterile solution for oral administration.
IGC-AD1-Placebo
A non-sterile solution for oral administration similar in color and texture to the Active.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
60 Years
ALL
No
Sponsors
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IGC Pharma, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Saadia Shahnawaz, MD
Role: STUDY_DIRECTOR
IGC Pharma, LLC
Locations
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ClinCloud, LLC
Maitland, Florida, United States
ClinCloud, LLC
Melbourne, Florida, United States
Global Medical Institutes Florida, LLC
Miami, Florida, United States
Miami Jewish Health
Miami, Florida, United States
Neurostudies Inc.
Port Charlotte, Florida, United States
BayCare Health System Inc.
St. Petersburg, Florida, United States
University of South Florida Department of Psychiatry and Behavioral Neurosciences
Tampa, Florida, United States
Tandem Intermediate, LLC
Metairie, Louisiana, United States
MedStar Franklin Square Medical Center Neurology
Baltimore, Maryland, United States
Medstar Georgetown University Hospital Neurology
Clinton, Maryland, United States
Medstar Montgomery Medical Center
Olney, Maryland, United States
Tekton Research LLC
St Louis, Missouri, United States
Dent Neurosciences Research Center
Amherst, New York, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, United States
Ichor Research
Syracuse, New York, United States
Lynn Health Science Institute (LHSI)
Oklahoma City, Oklahoma, United States
Butler Hospital, Brown University
Providence, Rhode Island, United States
Senior Adults Specialty Research
Austin, Texas, United States
Dominion Medical Associates, Inc.
Richmond, Virginia, United States
Island Health Authorities
Victoria, British Columbia, Canada
Hamilton Health Sciences , Mcmaster University
Hamilton, Ontario, Canada
Baycrest Academy, University of Toronto
Toronto, Ontario, Canada
Douglas Hospital Research Center, McGill university
Montreal, Quebec, Canada
Grupo de Neurociencias de Antioquia, Universidad de Antioquia
Medellín, Antioquia, Colombia
Instituto Sanacoop
Bayamón, Bayamón, Puerto Rico
SCB Research Center
Bayamón, , Puerto Rico
University of Puerto Rico
Rio Piedras, , Puerto Rico
Countries
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Central Contacts
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Other Identifiers
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IGC-AD1-P2 BIDAG
Identifier Type: -
Identifier Source: org_study_id