Clinical trial: The Study of Nasal Insulin in the Fight Against Forgetfulness (SNIFF) (NCT01767909)

Eligibility criteria:
Inclusion Criteria:

          -  Fluent in English or Spanish

          -  Diagnosis of aMCI by Petersen criteria or probable AD by National Institute of
             Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related
             Disorders Association (NINCDS-ADRDA) criteria

          -  Mini Mental State Examination (MMSE) score at screening is greater than or equal to 20

          -  Clinical Dementia Rating is 0.5-1 at screening

          -  Logical Memory is less than or equal to 8 for 16 or more years of education, less than
             or equal to 4 for 8-15 years of education, less than or equal to 2 for 0-7 years of
             education. Scores measured at screening on Delayed Paragraph Recall (Paragraph A only)
             from the Wechsler Memory Scale-Revised

          -  Able to complete baseline assessments

          -  Modified Hachinski score of less than or equal to 4

          -  A study partner able to accompany the participant to most visits and answer questions
             about the participant

          -  The study partner must have direct contact with the participant more than 2 days per
             week (minimum of 10 hours per week) and provide supervision of drug administration as
             needed

          -  Stable medical condition for 3 months prior to screening visit

          -  Stable medications for 4 weeks prior to the screening and baseline visits

          -  Stable use of permitted medications

          -  At least six years of education or work history

          -  Clinical laboratory values must be within normal limits or, if abnormal, must be
             judged to be clinically insignificant by the investigator

          -  Visual and auditory acuity adequate for neuropsychological testing

        Exclusion Criteria:

          -  A diagnosis of dementia other than probable AD

          -  Probable AD with Down syndrome

          -  History of clinically significant stroke

          -  Current evidence or history in past two years of epilepsy, focal brain lesion, head
             injury with loss of consciousness or Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (DSM IV) criteria for any major psychiatric disorder
             including psychosis, major depression, bipolar disorder, alcohol or substance abuse

          -  Sensory impairment that would preclude the participant from participating in or
             cooperating with the protocol

          -  Diabetes (type 1 or type II) requiring pharmacologic treatment (including both insulin
             dependent and non-insulin dependent diabetes mellitus)

          -  Current or past use of insulin or any other anti-diabetic medication

          -  Evidence of any significant clinical disorder or laboratory finding that renders the
             participant unsuitable for receiving investigational drug including clinically
             significant or unstable hematologic, hepatic, cardiovascular, pulmonary, endocrine,
             metabolic, renal or other systemic disease or laboratory abnormality.

          -  Active neoplastic disease, history of cancer five years prior to screening (history of
             skin melanoma or stable prostate cancer are not excluded)

          -  History of seizure within the past five years

          -  Pregnancy or possible pregnancy

          -  Contraindications to Lumbar Puncture (LP) procedure: prior lumbosacral spine surgery,
             severe degenerative joint disease or deformity of the spine, platelets is less than
             100,000 or history of bleeding disorder

          -  Use of anticoagulants warfarin (Coumadin) and dabigatran (Pradaxa) due to LP
             requirement

          -  Contraindications for MRI (claustrophobia, craniofacial metal implants of any kind,
             pacemakers)

          -  Residence in a skilled nursing facility at screening

          -  Use of an investigational agent within two months or screening visit

          -  Regular use of narcotics, anticonvulsants, medications with significant
             anticholinergic activity, antiparkinsonian medications or any other exclusionary
             medications
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Contradiction