Alzheimer DiseasePhase 2CALMANCT05543681
Clinical Trial on Agitation in Alzheimer's Dementia
A Phase 2 study testing IGC-AD1-Active in people with Alzheimer Disease and Agitation,Psychomotor, run by IGC Pharma, LLC at 28 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease, Agitation,Psychomotor, Care Giving Burden
- What is being tested?
- IGC-AD1-Active
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 28 sitesin 3 countries
- Study dates
- 11 Oct 2022to Nov 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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 6 weeks 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:
Who cannot join
- 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.
- 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 six weeks 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).
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
United States21 sites
Dent Neurologic Institute
Amherst, New York, 02459
Senior Adults Specialty Research
Austin, Texas, 78757
MedStar Franklin Square Medical Center Neurology
Baltimore, Maryland, 21237
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229
Medstar Southern Maryland Hospital Center
Clinton, Maryland, 20735
Baylor Scott and White Research Institute
Dallas, Texas, 75231
Kerwin Medical Center
Dallas, Texas, 75231
ClinCloud, LLC
Maitland, Florida, 32751
ClinCloud, LLC
Melbourne, Florida, 32940
Tandem Clinical Research GI, LLC
Metairie, Louisiana, 70006
Central Miami Medical Institute
Miami, Florida, 33125
Visionary Investigators Network
Miami, Florida, 33133
Miami Jewish Health
Miami, Florida, 33137
Lynn Health Science Institute (LHSI)
Oklahoma City, Oklahoma, 73112
Medstar Montgomery Medical Center
Olney, Maryland, 20832
Neurostudies Inc.
Port Charlotte, Florida, 33952
Butler Hospital, Brown University
Providence, Rhode Island, 02906
Dominion Medical Associates, Inc.
Richmond, Virginia, 23219
Tekton Research LLC
St Louis, Missouri, 63128
Ichor Research
Syracuse, New York, 13210
University of South Florida Department of Psychiatry and Behavioral Neurosciences
Tampa, Florida, 33613
Canada4 sites
Hamilton Health Sciences , Mcmaster University
Hamilton, Ontario, L8M 1W9
Douglas Hospital Research Center, McGill university
Montreal, Quebec, H4H 1R3
Baycrest Academy for Research and Education , University of Toronto
Toronto, Ontario, ON M6A 2E1
Island Health Authorities
Victoria, British Columbia, V8R 1J8
Puerto Rico3 sites
Instituto Sanacoop
Bayamón, Bayamón, 00961
SCB Research Center Corp
Bayamón, 00961
The Alliance, Medical Sciences Campus University of Puerto Rico
Rio Piedras, 00935
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Alzheimer Disease, Agitation,Psychomotor, Care Giving Burden, NPS, Aggression
- Being tested
- IGC-AD1-Active, IGC-AD1-Placebo
- Keywords
- Cannabis, Tetrahydrocannabinol, THC, Melatonin, Alzheimer's, Marijuana, Hemp, Agitation, Dementia, Depression, Anxiety, NPI, CMAI, Dronabinol
- Medical subject headings
- Alzheimer Disease, Psychomotor Agitation, Caregiver Burden, Aggression, Marijuana Abuse, Dementia, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGC-AD1-ActiveDrug
Also called Active
A non-sterile solution for oral administration.
IGC-AD1-PlaceboDrug
Also called Placebo
A non-sterile solution for oral administration similar in color and texture to the Active.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: IGC-AD1Active | Active comparator | IGC-AD1-Active, oral solution with two APIs (THC and melatonin). Receives: Drug: IGC-AD1-Active |
| Placebo Comparator: IGC-AD1 Placebo | Placebo comparator | IGC-AD1-Placebo, oral solution similar to Active in color, taste, and texture, with excipients but without APIs. Receives: Drug: IGC-AD1-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agitation
Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
Measured: Baseline to week six
Secondary outcomes (1)
Acute Agitation
Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
Measured: Baseline to week two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start11 Oct 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IGC Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543681
- Sponsor's protocol ID
- IGC-AD1-P2 BIDAG
- Acronym
- CALMA
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No