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.
Consistent use of medications for behavioral symptoms.
Objectives
Primary
Secondary
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
Participants
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
