Clinical trial: SNIFF 120: Study of Nasal Insulin to Fight Forgetfulness (120 Days) (NCT00438568)

Eligibility criteria:
Inclusion Criteria:

          -  Age 55 or greater

          -  Good physical health

          -  Memory impairment with a diagnosis of mild cognitive impairment (MCI) or Alzheimer's
             disease (AD)

          -  Participants on stable doses of Memantine (Namenda) or cholinesterase inhibitors will
             be eligible

        Exclusion Criteria:

          -  Chronic sinus problems/allergies with chronic use of nasal decongestants or
             antihistamines

          -  Significant neurologic disease that might affect cognition (other than AD), such as
             stroke, Parkinson's disease, multiple sclerosis, severe head injury with loss of
             consciousness for more than 30 minutes or with permanent neurologic symptoms

          -  Significant medical illness or organ failure, such as uncontrolled hypertension or
             cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or
             kidney disease

          -  Preexisting diabetes or current or previous use of hypoglycemic agents or insulin;
             participants will be excluded if they have a fasting blood sugar greater than 165 on
             baseline OGTT

          -  Clinically significant elevations in liver function tests, cholesterol, or
             triglycerides

          -  Major psychiatric disorders (e.g., untreated major depression and schizophrenia)

          -  Chronic use of the following types of medications: anti-psychotic, anxiolytic, and
             opiates
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.


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