Start: December 2012
End: February 2025
What Is This Study About?
This study will test the effectiveness of the experimental drug BAN2401 as a possible treatment for people with mild cognitive impairment (MCI) or mild Alzheimer's disease.
Do I Qualify To Participate in This Study?
- Positive amyloid load as indicated by PET brain scan
- MMSE score of 22-30 inclusive at screening and beginning of trial
- Body mass index of less than 35
- Women must not be pregnant or lactating, and specified contraceptive precautions must be followed.
- If taking acetylcholinesterase inhibitor or memantine, must be on a stable dose for at least 12 weeks
- Available, identified caregiver
Participants with Mild Cognitive Impairment due to Alzheimer's
- Intermediate likelihood of MCI according to National Institute of Aging-Alzheimer's Association (NIA-AA) core clinical criteria
- Clinical Dementia Rating score of 0.5; Memory Box score of 0.5 or greater
- History of subjective memory decline, with gradual onset and slow progression during the year before screening, corroborated by a family member or friend
- Objective impairment in episodic memory, as indicated by the Wechsler Memory Scale, 4th edition
Participants with Mild Alzheimer's Dementia
- Probable Alzheimer's dementia according to NIA-AA core clinical criteria
- Clinical Dementia Rating score of 0.5-1.0; Memory Box score of 0.5 or greater
Must NOT have:
- Any neurological condition besides Alzheimer's disease that may be contributing to cognitive impairment
- History of transient ischemic attack (TIA), stroke, or seizure within 12 months of screening
- Any psychiatric diagnosis or symptoms (for example, hallucinations, major depression, or delusions) that could interfere with study procedures
- Contraindications to MRI scanning, including cardiac pacemaker/ defibrillator or magnetic metal implants
- MRI evidence of clinically significant lesions that could indicate a dementia diagnosis other than Alzheimer's disease or other significant pathological findings
- Prolonged QT/QTc interval (QTc > 450 ms) as shown by a repeated electrocardiogram (ECG)
- Severe visual or hearing impairment that would prevent accurate performance on psychometric tests
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 about this study or study locations, contact Eisai Medical Services at 1-888-422-4743.
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: Eisai Inc.
Source: ClinicalTrials.gov ID: NCT01767311