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Clinical Trial on Agitation in Alzheimer's Dementia (CALMA)
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.
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
- CALMA
- IGC-AD1-P2 BIDAG
Tetrahydrocannabinol
THC
Melatonin
Alzheimer's
Marijuana
Hemp
Agitation
Dementia
Depression
Anxiety
NPI
CMAI
Dronabinol
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Aktives VergleichspräparatActive 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-VergleichspräparatPlacebo 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. |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Agitation | Change in mean Cohen Mansfield Agitation Inventory (CMAI) score | Baseline to week six |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Acute Agitation | Change in mean Cohen Mansfield Agitation Inventory (CMAI) score | Baseline to week two |
Participant and/or Caregiver must provide a signed and dated ICF prior to any study procedures.
Must have a Caregiver who is able and willing to comply with all required study procedures.
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.
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.
Participants must consent to CYP450 and apolipoprotein E (ApoE) genotyping, and pharmacokinetics.
Diagnosis of AD by NIA-AA criteria
Clinically significant Agitation assessed by:
- NPI (Agitation) ≥ 4
- The presence of clinically significant, persistent Agitation based on the IPA definition (Appendix C) rather than those with recent onset and occasional symptoms, and
- Agitation not attributable to another psychiatric disorder, suboptimal care conditions, other underlining medical condition, or the physiological effects of a substance.
Negative drug screen, except for benzodiazepines if Participant has been using them in stable doses for at least 3 months before screening.
All medications used for behavioral symptoms should be consistent for at least 3 months before screening, with allowance for dose changes up to 25%.
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:
- 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.
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease, which might confound assessment of safety outcomes.
- History of seizures, schizophrenia, or bipolar disorder.
- Has participated in an investigational drug or device study within 30 days prior to study start.
- 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.
- History of Alcohol and Drug use disorder, within one year prior to enrollment.
- 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.
- 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).
IGC Pharma, LLCFlorida
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Bayamón