Phase
Condition
Memory Problems
Dementia
Memory Loss
Treatment
Placebo (Insulin Diluent)
Placebo (Capsules)
Aptar Pharma CPS Intranasal Delivery Device
Clinical Study ID
Ages 55-85 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 55 to 85 (inclusive)
Fluent in English
Cognitively normal or diagnosis of amnestic mild cognitive impairment (aMCI) or mildAlzheimer's disease (AD)
Amyloid positive by positron emission tomography (PET) or cerebrospinal fluid (CSF)criteria
Stable medical condition for 3 months prior to screening visit
Stable medications for 4 weeks prior to the screening and study visits (exceptionsmay be made on a case by case basis by the study physician)
Clinical laboratory values must be within normal limits or, if abnormal, must bejudged to be clinically insignificant by the study physician
Exclusion
Exclusion Criteria:
A diagnosis of dementia other than Alzheimer's disease (AD)
History of a clinically significant stroke
Current evidence or history in past two years of epilepsy, head injury with loss ofconsciousness, any major psychiatric disorder including psychosis, major depression,bipolar disorder
Diabetes (type I or type II) insulin-dependent and non-insulin-dependent diabetesmellitus
Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit
History of seizure within past five years
Pregnancy or possible pregnancy
Use of anticoagulants, unless documentation received from prescribing clinician thatanticoagulant medication can be held before LP, and approved by study clinician
Residence in a skilled nursing facility at screening
Use of an investigational agent within two months of screening visit
Regular use of alcohol, narcotics, anticonvulsants, anti-parkinsonian medications,or any other exclusionary medications (exceptions may be made on a case by casebasis by the study physician)
Study Design
Study Description
Connect with a study center
Wake Forest University Health Sciences / Wake Forest School of Medicine
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.