Clinical Trial on Agitation in Alzheimer's Dementia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorIGC Pharma, LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Prior adverse reaction to cannabinoids or to any component of Study Drug (IGC-AD1 and placebo).
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.
Trial design
Design model
Parallel
Treatments tested in this trial
IGC-AD1-Active
DrugA non-sterile solution for oral administration.
IGC-AD1-Placebo
DrugA non-sterile solution for oral administration similar in color and texture to the Active.
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: Active Comparator: IGC-AD1ActiveActive comparator 1 intervention
Group B: Placebo Comparator: IGC-AD1 PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Agitation
Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
Time frame
Baseline to week sixSecondary outcomes
1
Acute Agitation
Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
Time frame
Baseline to week twoOther outcomes
1
Agitation at week four
Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
Time frame
Baseline to week four2
Participant overall wellbeing
Change in the Clinical Global Impression Scale (CGI)
Time frame
Baseline to weeks two and six3
Participant executive functions
Change in Mini-Mental State Examination (MMSE2) score
Time frame
Baseline to week six4
Depression
Change in mean Cornell Scale for Depression in Dementia (CSDD) score
Time frame
Baseline to weeks two, four, and sixSponsors and contacts
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Source ClinicalTrials.gov