Start: June 27, 2019
End: January 29, 2021
What Is This Study About?
This Phase II/III clinical trial will evaluate the efficacy and safety of the experimental drug azeliragon in adults with mild Alzheimer's disease and impaired glucose tolerance (at a level associated with type 2 diabetes).
Do I Qualify To Participate in This Study?
- Diagnosis of probable Alzheimer's disease with documented evidence of disease progression
- Mini-Mental State Examination score of 21 to 26
- Clinical Dementia Rating global score of 0.5 or 1
- Alzheimer's Disease Assessment Scale-Cognitive Subscale of 10 or more
- Brain magnetic resonance imaging consistent with diagnosis of probable Alzheimer's
- Use of Alzheimer's drugs must be on stable dose for at least 2 months prior to screening
- Hemoglobin A1c level of 6.5% to 9.5%
- Caregiver who can attend clinic visits with the participant
- Ability to ingest oral medications
Must NOT have:
- Significant neurological or psychiatric disease other than Alzheimer's
- Previous clinical trial participation within 90 days of screening
- Previous exposure to disease-modifying therapy for Alzheimer's disease within 1 year of screening
- History of cancer within last 5 years except treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or nonprogressive prostate cancer not requiring current treatment
- Women of childbearing potential
- Uncontrolled blood pressure and/or blood pressure above 140/90 mm Hg
- Participants receiving medications that may negatively impact cognitive function
- History of diabetic ketoacidosis within the past year
- History of chronic pancreatitis
- Stage 4 kidney disease
- Use of insulin therapy
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Who Is the General Study Contact?
For more information on this clinical trial or study sites, call 336-888-0435 or email email@example.com.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: vTv Therapeutics
Source: ClinicalTrials.gov ID: NCT03980730