MCI/MILD DEMENTIA STUDY (MMSE 22-30
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF IV INFUSION DRUG XXXXX IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER'S DISEASE.
1. Aged between 50 and 85 years at screening.
2. Weight between 40 and 120 kg.
3. Availability of a study partner who has sufficient contact with the patient to be able to provide accurate information regarding the patient's cognitive and functional abilities.
4. Willingness and ability to complete all aspects of the study including MRI and PET imaging.
5. Mild dementia symptomatology, as defined by a screening MMSE score of ≥ 22 points.
6. If the patient is receiving symptomatic Alzheimer's Disease medications, the dosing regimen must have been stable for 3 months prior to screening.
1. Any evidence of a condition other than Alzheimer's Disease that may affect cognition, ex. frontotemporal dementia, Lewy bodies, vascular, Parkinson's, normal pressure hydrocephalus, seizure disorder etc.
2. Clinically evident vascular disease that could potentially affect the brain (e.g., clinically significant carotid, vertebral stenosis or plaque; aortic aneurysm; intracranial aneurysm; cerebral hemorrhage).
3. Stroke with clinical symptoms within the past 2 years, or history within the last 6 months of TIA.
4. CNS trauma/ intracranial tumor/infections (e.g., glioma, meningioma)/ HIV, syphilis, neuroborreliosis, viral or bacterial meningitis/encephalitis.
5. Systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits multiple sclerosis, lupus erythematosus etc.
6. History of schizophrenia,, major depression, or bipolar disorder. Major depression is acceptable if patient has no episode within the past year or is considered in remission or controlled by treatment.
7. High risk of suicide.
8. Alcohol and/or substance abuse or dependence within the past 2 years Nicotine use is allowed. Marijuana use is not allowed and must be discontinued 3 months before screening.
9. MRI evidence of; > 2 lacunar infarcts, any territorial infarct > 1 cm, evidence of more than 4 microbleeds and/or areas of leptomeningeal hemosiderosis (ARIA-H).
10. Inability to tolerate MRI procedures or contraindication to MRI.
11. History or presence of atrial fibrillation except if only 1 episode that resolved > 1 year ago and for which treatment is no longer indicated â€“ Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g., myocardial infarction, angina pectoris, or Class II or higher cardiac failure).
12. Uncontrolled hypertension (BP > 160 mmHg systolic or > 95 mmHg diastolic).
13. Chronic kidney disease of Stage ≥ 4.
14. Impaired hepatic function; AST or ALT ≥ 3 the upper limits, (ULN) or total bilirubin ≥ 2 ULN.
15. Hepatitis B or C infection that has not been adequately treated.
16. Screening hemoglobin A1c (HbA1C) > 8%.
17. Sleep apnea sufficient to require oxygen treatment.
18. Impaired coagulation (screening PT > 1.2 x the ULN that remains abnormal on retest).
19. Cancer, currently undergoing treatment. Exception and allowed in the study if not likely to require treatment in the ensuing 5 years. For prostate or basal cell, no significant progression over the previous 2 years is allowed.
20. Medications that are not allowed:
Typical antipsychotic or neuroleptic medication within 6 months of screening except as brief treatment for a non-psychiatric indication e.g., emesis.
Any previous treatment with medications specifically intended to treat Parkinsonian symptoms or any other neurodegenerative disorder within 1 year of screening.
Anti-coagulation medications within 3 months of screening. Anti-platelet treatments (e.g., aspirin, clopidigrel, dipyridamol) are permitted.
Chronic use of opiates or opioids (including long-acting opioid medication) within 3 months of screening.
Chronic use of benzodiazepines, barbiturates, or hypnotics from 3 months before screening.
We're here to help. Send us an email or call us at 702.750.0222
REQUEST A FREE CONSULTATION