GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer’s Disease
safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of
mild to moderate AD dementia.
– Subject has probable AD dementia according to the NIA-AA criteria.
– Subject has an MMSE score 12 and 24 inclusive at both screening and Visit 2 and a
≤3-point difference between these visits.
– Subject has brain MRI scan consistent with the diagnosis of AD performed during the
screening period. Computed Tomography scan can be used only if the subject has an
absolute contraindication for MRI.
– Subject has a Modified Hachinski score ≤4 at screening.
– Subjects with background symptomatic therapy with acetylcholine esterase inhibitors,
and/or memantine, are allowed as long as the dose has been stable for 90 days prior to
screening and no changes are planned during the study.
– Subject has a primary caregiver willing to accept responsibility for supervising the
treatment (e.g., administering study drug) and assessing the condition of the subject
throughout the study in accordance with all protocol requirements.
– Subject has body mass index <38 kg/m2 at Screening
Key Exclusion Criteria:
- Subject has imaging consistent with a dementia diagnosis other than AD.
- Subject has had an increase or restoration of cognition based on medical history.
- Subject with history or current evidence of major psychiatric illness such as
schizophrenia, bipolar disorder, or major depressive disorder that may interfere with
the patient's ability to perform the study and all assessments. NOTE: Mild depression
or depressive mood arising in the context of AD are not criteria for exclusion. The
use of anti-depressants or the use of anti epileptic medication for non
seizure-related treatment is allowed if the dose has remained stable for at least 60
days prior to enrollment.
- Subject has any of the following laboratory findings at screening:
1. Alanine aminotransferase >3 x upper limit of normal (ULN), aspartate
aminotransferase >3 x ULN, or history of clinically significant liver disease in
the Investigator’s judgment.
2. Hemoglobin ≤10 g/dl.
3. Creatinine clearance (CL) of <45 ml/min. 4. Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) >8.
5. Positive blood screen for Human Immunodeficiency Virus (HIV 1 and 2), Hepatitis B
surface antigen (HBsAg), or Hepatitis C virus antibodies (HCV-Ab) at Screening.
- ATP Clinical Research, Inc., Costa Mesa, California, United States, 92626
- Alliance Research, Long Beach, California, United States, 90807
- Standford University, Palo Alto, California, United States, 94305
- CITRIALS, Riverside, California, United States, 92506
- CITRIALS, Santa Ana, California, United States, 92705
- Syrentis Clinical Research, Santa Ana, California, United States, 92705
- Southern California Research LLC, Simi Valley, California, United States, 93065