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Our Phase II Clinical Trial

As millions of Alzheimer’s patients experience agitation, our ongoing Phase II trial brings hope for a treatment.

Phase II Multi-Center, 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.

Have a caregiver who can comply with required procedures.

Diagnosis of probable AD by NIA-AA criteria.

Clinically significant Agitation assessed by the NPI.

Consistent use of medications for behavioral symptoms.



Assess the efficacy of IGC-AD1 in participants with agitation associated with dementia due to Alzheimer’s disease in a six-week, placebo- controlled trial using the Cohen-Mansfield Agitation Inventory (CMAI).


Assess the efficacy of IGC-AD1 in participants with agitation associated with dementia due to Alzheimer’s disease in a two-week period, as part of the placebo-controlled trial using the CMAI.

Assess clinician's impressions of participant's global functioning.

Assess the efficacy of IGC-AD1 on neuropsychiatric symptoms.

Assess the change in caregiver burden.

Assess pharmacokinetics, ApoE and CYP2C9 polymorphisms, and CNS related biomarkers.

Measure the number and severity of Adverse Events.

Measure the changes in cognitive processes.

Measure the changes in rescue medications.

Assess the impact of IGC-AD1 in patient’s quality of life.

Study Design


The trial enrolls 164 participants, and the expected dropout rate is around 10%.

Enrolled participants receive IGC-AD1 or Placebo for 44 days.

Recruitment Strategies

· Site/hospitals patient databases
· Private practice databases
· Referrals from primary care and  other physicians
· Community outreach and advertising
· Direct patient contact

In Clinic

Week 0 – Week 2 – Week 4 – Week 6

Safety Calls

Daily for three days.
Afterwards every third day to review safety and compliance

Clinical Trial Locations

4161 Tamiami Trail, Suite 201 Port Charlotte, Fl, 33952 

Site 1100

719 NW 13th Avenue Miami, FL 33125 

Site 1200

7000 Spyglass Court Ste 130 1st Floor Melbourne, FL 32940 

Site 700

1551 Sandspur Road Maitland, FL 32751 

Site 700

9000 Franklin Square Drive Neurosciences Administration Wing Baltimore, MD 21237

Site 400

18101 Prince Philip Dr. Olney, MD 20832

Site 400

10401 Hospital Dr.  Suite 102, Clinton, MD 20735 

Site 400  

180 Wells Ave., Suite 304 Newton, MA 02459 

Site 800  

3980A Sheridan Drive Amherst, NY 14226 

Site 900 

3560 Bathurst Street, Kimel Family Building, Toronto, ON M6A 2E1 

Site 1000 

6875 Boulevard LaSalle, Verdun, Quebec, Canada, H4H 1R3 

Site 1300  

B7 Santa Cruz Street, Bayamón, 00961, Puerto Rico

Site 100

73 Santa Cruz Street Suite 405, Bayamón, 00961, Puerto Rico

Site 200

The Alliance 1er Piso Hospital Universitario Rio Piedras, PR 00935 

Site 300