Last updated 32 days ago
Clinical Trial on Agitation in Alzheimer's Dementia
164 patients around the world
Available in Puerto Rico
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.
IGC Pharma, LLC
1Research sites
164Patients around the world
This study is for people with
Alzheimer disease
Requirements for the patient
From 60 Years
All Gender
Medical requirements
- 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 Power of Attorney, is a spouse, or a sibling or a child or a close relation.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 rather than those with recent onset and occasional symptoms.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 or surgically sterile.
- Prior adverse reaction to cannabinoids or to any component of Study Drug.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.
Sites
Universidad de Puerto Rico - Recinto de Río Piedras
Recruiting
StudyCALMA
SponsorIGC Pharma, LLC
Study typeInterventional
Conditions
Alzheimer disease
Requirements
From 60 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05543681
