A Phase 2A Multicenter Randomized Double-Blind Parallel Group 26-Week Placebo-Controlled Study of 50 mg and 100 mg of SUVN-502 in Subjects with Moderate Alzheimer's Disease Currently Treated with Donepezil Hydrochloride and Memantine Hydrochloride
Martin Farlow, MD
Primary Investigator
Overview
The purpose of this study is to see if SUVN 502 has an effect in improving symptoms of Alzheimer?s disease, to see if it is safe, to see how well it is tolerated, and to measure the levels of SUVN 502 in the blood.
Description
The purpose of this study is to see if SUVN-502 has an effect in improving symptoms of Alzheimer's disease, to see if it is safe, to see how well it is tolerated, and to measure the levels of SUVN-502 in the blood in subjects with moderate Alzheimer's disease who are currently taking the marketed medications donepezil hydrochloride (HCI)and memantine (HCI).
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Alzheimer's disease
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Age: Between 50 Years - 85 Years
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Gender: All
Inclusion Criteria
Has a diagnosis of probable Alzheimer's disease at least 1 year prior to the screening visit
Has a MRI or CT scan performed within 12 months prior to screening with findings consistent with the diagnosis of dementia due to Alzheimer's disease without any other clinically significant comorbid pathologies
Must be receiving treatment with stable doses of donepezil HCI, either as 10 mg donepezil only or part of the combination therapy, Namzaric qd for at least 3 months prior to screening visit
Must be receiving treatment with stable doses of memantine HCI or Namenda XR or as part of the combination therapy, Namzaric qd for at least 3 months prior to the screening visit
Availability of a person who in the investigator's judgment has frequent and sufficient contact with the subject, such that the person is qualified, willing and able to provide accurate information regarding the subject's cognitive and functional abilities and will accompany the subject to study visits
Must be living in the community or an assisted living facility
Must be ambulatory or ambulatory aided (use of cane or walker)
Must have vision and hearing (corrected) sufficient to comply with the resting procedures
Both subject and caregiver must be able to read and understand English and have appropriate literacy skills to ensure compliance with the testing and study procedures
Is not pregnant or planning to become pregnant during the study
Exclusion Criteria
Has a diagnosis of dementia due to other causes
Has diagnosis of schizophrenia, bipolar disorder or current major depressive disorder (MDD) or subjects whose C-SDD scores are suggestive of probable depression
Taking cholinesterase inhibitors other than donepezil HCI
Has uncontrolled cardiac disease or hypertension
Has bradycardia or tachycardiaon the ECG at screening
Has uncontrolled Type-1 or Type-2 diabetes
Has cancer or a malignant tumor, or has been treated for an active malignancy within the past 5 years
Has untreated thyroid disorder
Has a history of seizure disorder
Has clinically significant renal or hepatic impairment
Has any clinically significant abnormal laboratory values
Has abnormal vitamin B-12 levels that are lower than normal limits and remains low on repeat testing
Has participated in a previous clinical study within 26 weeks of the screening visit, or has been previously treated with the investigational product, SUVN-502
Subject (or caregiver) is deemed otherwise ineligible for participation in this study in the investigator's judgment
