Study of Nasal Insulin to Fight Forgetfulness (SNIFF)

What Is This Study About?

This Phase II/III clinical trial will examine whether a type of insulin, when administered as a nasal spray, improves memory in adults with a mild cognitive impairment or Alzheimer’s disease. The study will also provide evidence about how intranasal insulin works in the body.

Do I Qualify To Participate in This Study?

Must have:

• Diagnosis of amnestic MCI or probable mild Alzheimer's disease, according to the core clinical criteria outlined in the NIA and Alzheimer's Association guidelines
• Mini-Mental State Examination (MMSE) score of 20 or higher at screening; Clinical Dementia Rating of 0.5-1 at screening; Logical Memory score of 8 or lower for 16 or more years of education, 4 or lower for 8-15 years of education, 2 or lower for 0-7 years of education
• Modified Hachinski score of less than or equal to 4
• Study partner able to accompany the participant to most visits and answer questions about the participant; partner must have direct contact with the participant more than 2 days per week (minimum of 10 hours per week) and supervise drug administration as needed
• Stable medical condition for 3 months prior to screening
• Stable medications for 4 weeks prior to screening and baseline visits
• At least 6 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
• Adequate seeing and hearing ability to complete neuropsychological testing
• Fluency in English or Spanish

Must NOT have:

• Diagnosis of dementia other than probable Alzheimer's disease
• Probable Alzheimer's with Down syndrome
• History of clinically significant stroke
• Current evidence or history in past 2 years of epilepsy, focal brain lesion, or head injury with loss of consciousness
• Major psychiatric disorder, including psychosis, major depression, bipolar disorder, or alcohol or substance abuse
• Sensory impairment that precludes participation in the study
• Diabetes (type I or II) requiring pharmacologic treatment (including both insulin-dependent and non-insulin dependent diabetes mellitus)
• Clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality
• Active neoplastic disease
• History of cancer in 5 years prior to screening (history of skin melanoma or stable prostate cancer are allowable)
• Seizure within the past 5 years
• Other significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving intranasal insulin
• Pregnancy or possible pregnancy
• Contraindication to lumbar puncture, such as prior lumbosacral spine surgery, severe degenerative joint disease, or deformity of the spine
• Platelet count of less than 100,000 or history of bleeding disorder
• Use of anticoagulants warfarin (Coumadin) or dabigatran (Pradaxa)
• Contraindication to magnetic resonance imaging, such as claustrophobia, craniofacial metal implant of any kind, or pacemaker
• Residence in a skilled nursing facility at screening
• Use of an investigational agent within 2 months of screening visit
• Regular use of narcotics, anticonvulsants, medications with significant anticholinergic activity, or antiparkinsonian medications

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Who Is the General Study Contact?

For more information on this trial, contact sniff-participate@usc.edu.

Where Is This Study Located?

Who Sponsors This Study?

Lead: Wake Forest University

Collaborator Sponsor

• University of Southern California, Alzheimer's Therapeutic Research Institute

Source: ClinicalTrials.gov ID: NCT01767909