Short Term Efficacy and Safety of Perispinal Administration of Etanercept in Mild to Moderate Alzheimer's Disease

This is an interventional health services research trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Dementia, Cognitive decline, Cognitive disorder, Degenerative brain disease, Cognitive impairment, Memory loss, TNF-alpha Read More

Inclusion Criteria:

• Subject is aged 60-85 years
• Subject has a diagnosis of Alzheimer's disease according to the NINCDS- ADRDA criteria (National Institute of Neurological and Communicative Disorders and Stroke NINCDS] and Alzheimer's Disease and Related Disorders Association [ADRDA]).
• Subject is not institutionalized (for example, lives independently, lives independently in a residential home for the elderly, or is a day patient at a care center)
• Subject has a Hachinski Ischemia Score of ≤ 4.
• Subject has a total MoCA score of < 26 at screening.
• Subject has an MMSE score of 11 to 24 at screening.
• Subject has an ADAS-cog score of 12 to 25 at screening.
• Subject has experienced a gradual and progressive cognitive decline in the 6 months before the screening visit.
• Subject provides informed consent to participate in the study or has a legally acceptable representative who provides consent.
• Subject has a responsible caregiver who consents to supporting the subject in his/her study participation (for example, by accompanying the subject on each study visit).
• Subject is surgically sterile, agrees to use an acceptable method of birth control as defined in section 5.4 or, for females, is post- menopausal.
• Subject agrees to stop taking any vitamin, mineral, or dietary supplements he/she is currently taking that have any components of the nutritional supplements utilized in the study at least 7 days before randomization (Visit 2) and agrees to not use any new vitamin, mineral, or dietary supplement product other than those provided by the investigator until after the subject is discharged from the study.

Exclusion Criteria:

• A neurologic disorder, such as seizures, multiple sclerosis, neurodegenerative disorders (eg, Parkinson's disease), or dementia other than Alzheimer's type (including that caused by small strokes or cerebrovascular disease)
• Cognitive impairment from any condition other than Alzheimer's disease, such as that resulting from acute cerebral trauma, cerebral damage due to a lack of oxygen, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor
• Cardiovascular or cerebrovascular disease, such as congestive heart failure, uncontrolled hypertension (BP ≥ 140/90 mmHg at screening), and a history of stroke
• Renal impairment/disease, defined as serum creatinine > 1.5 mg/dL
• Hepatic impairment, defined as Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 3 times the upper limit of normal OR has a history of a positive blood screen for hepatitis B surface antigen or hepatitis C antibody.
• Type I or II diabetes mellitus
• Significant or uncontrolled psychiatric disease
• Gastrointestinal disease, such as active peptic ulcer, gallstones, gallbladder disease, or biliary tract obstruction, or a history of cholecystectomy
• Hematologic disorders
• Pulmonary or lung disorders
• Immune system disorder, such as HIV/AIDS
• History of cancer within 10 years before screening (except localized skin cancer without metastases or in situ cervical cancer)
• History of chronic or recurrent infection (including tuberculosis) OR, in the 7 days before Visit 2 (randomization), any known infection or body temperature > 38.6º C (101.5º F)
• Subject is pregnant or breastfeeding at screening.
• Subject has intolerance or allergy to Enbrel®, latex, or any of Enbrel's components.
• Subject is currently consuming more than 6 standard alcoholic beverages a week. A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor.
• Subject is currently taking and unable or unwilling to stop taking anticoagulant or antiplatelet herbs and supplements such as angelica, clove, danshen, garlic, ginger, ginkgo, Panax ginseng, red clover, or willow for at least 7 days before the randomization visit (Visit 2) and throughout the study.
• Subject is currently taking and unable or unwilling to stop taking any of the prohibited medications in protocol section 5.3.2 for at least 7 days before the randomization visit (Visit 2) and throughout the study.
• Subject had major surgery within the 4 weeks before screening.
• Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
• Subject is participating or has participated in another research study within 30 days before the screening visit
• Subject or subject's caregiver is unable or unwilling to comply with the study procedures.