MCI/MILD DEMENTIA STUDY (MMSE 20-36)

Protocol: 
Multicenter, randomized, parallel-group, 78-week-long double-blind (DB), placebo-controlled, study of 2 fixed dose levels of oral formulation drug XXXX in patients with mild AD and abnormal levels of amyloid, followed by a 78-week-long delayed-start period. 

Objective: 
Drug XXXX is being developed for the modification of the clinical course of Alzheimer's Disease (AD) by slowing disease progression in patients diagnosed with early Alzheimer's Disease, which is defined as the continuum of patients with mild cognitive impairment due to AD (MCI-AD) and patients diagnosed with mild dementia of the Alzheimer's type (mild Alzheimer's Disease). 

Inclusion Criteria:

1. Male or female, aged 55 to 85 years.

2. Gradual and progressive change in the patient's memory function over more than 6 months, reported by patient and study partner.

3. MMSE score of 20 to 26.

4. PET visual reading concentration positive for presence of amyloid.

5. Patient treated with cholinesterase inhibitors/ memantine, the following conditions must also be met:

(a) Patient has been on the dose regimen for at least 90 days a stable dose of 60 days.

(b) Patient agrees to keep the dosage regimen stable for the duration of the study.

6. Patient agrees to undergo ApoE genotyping.

7. Patient must have a reliable study partner with whom he/she cohabits or has regular contact.

 

Exclusion Criteria:

1. Significant neurological disease affecting the CNS, other than Alzheimer's Disease, that may affect cognition; other dementias, serious infection of the brain, Parkinson's, epilepsy or recurrent seizure.

2. Multiple strokes based on history or imaging results.

3. History of clinically important carotid or vertebrobasilar stenosis or plaque.

4. History of multiple concussions or a concussion with sustained cognitive complaints or objective change in neuropsychological function in the last 5 years.

5. Patients with uncontrolled Major Depressive Disorder (MDD) or any current primary psychiatric diagnosis, schizophrenia or other chronic psychosis.

6. History of alcohol or drug abuse or dependence (except nicotine dependence) within 2 years.

7. Within 1 year, myocardial infarction; moderate or severe congestive heart failure, unstable angina, syncope, significant valvular disease, hypertrophic cardiomyopathy or hospitalization for arrhythmia.

8. Congenital QT prolongation, corrected QT (QTcF) interval measurement >470 msec, Intermittent second-or third-degree atrioventricular (AV) heart block.

9. History of cancer within the last 5 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical, or non-progressive prostate cancer.

10. Screening MRI shows >5 microhemorrhages;≥4 lacunar infarcts, or single infarct >1 cm3.

11. Uncontrolled hypertension, that is, supine systolic BP >165 mmHg or diastolic BP >95 mmHg.

12. HIV, Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies.

13. Urine drug screen positive for amphetamine, cocaine, phencyclidine, or barbiturate. Positive for cannabinoid is exclusionary, unless the patient will likely abstain from use for the duration of the study.

14. Calculated creatinine clearance <30 mL/min.

15. ALT ≥2 x the upper limit, AST ≥2 x ULN, total bilirubin ≥1.5 x ULN, or ALP ≥1.5x ULN.

16. Regular use of narcotic medications within 30 days.

17. Use of drugs known to significantly prolong the QT interval.

18. Contraindications for MRI studies, including claustrophobia, presence of metal etc.

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