Non-invasive method for diagnosing alzheimer's disease in a patient

• US 6,162,186 A
• Filed: 11/09/1999
• Issued: 12/19/2000
• Est. Priority Date: 07/25/1994
• Status: Expired due to Fees

• Current Assignee: BETH Israel Deaconess Medical Center (Caregroup Incorporated)
• Original Assignee: BETH Israel Deaconess Medical Center (Caregroup Incorporated)
• Inventors: Daffner, Kirk R., Scinto, Leonard
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US09/436,401
• Time in Patent Office: 406 Days
• Field of Search: 600/558
• US Class Current: 600/558
• CPC Class Codes: A61B 3/112 for measuring diameter of pupils
• CPC Class Codes: A61B 5/16 Devices for psychotechnics using teaching or educational appliances G09B1/00 - G09B7/00; Testing reaction times ; Devices for evaluating the psychological state
• CPC Class Codes: A61B 5/163 by tracking eye movement, gaze, or pupil change
• CPC Class Codes: A61B 5/4088 Diagnosing of monitoring cognitive diseases, e.g. Alzheimer, prion diseases or dementia

Abstract

The present invention provides non-invasive methods for diagnosing Alzheimer'"'"'s disease in a living human subject. One method employs a non-invasive automated apparatus which can continuously monitor pupil diameter size over time; repetitively measure pupil diameter size over time for a pre-chosen duration ranging from about less than 1 second to about 5 minutes; and cumulatively record size information as it is obtained over time. A second method employs an apparatus which can repetitively measure pupil constriction velocity for a pre-chosen duration both before and after stimulation by visible light. Both methods require the administration of at least one neural transmitter mediator to a targeted eye of the living subject in an amount insufficient to cause marked changes in pupil diameter size over time in a person who is not afflicted with Alzheimer'"'"'s disease. The marked hypersensitivity of an Alzheimer'"'"'s dementia patient to the administered neural transmitter mediator serves as the means for identifying individuals afflicted with Alzheimer'"'"'s disease.

Claims

1. A pharmaceutical composition for topical application to the eye of a subject, comprising a concentration of tropicamide insufficient to cause a measurable pupillary response in a normal individual, but sufficient to cause a measurable pupillary response in an individual afflicted with Alzheimer'"'"'s disease and wherein said concentration is less than 0.01%.

2. The pharmaceutical composition of claim 1, wherein said tropicamide is present at a concentration of at least 0.0025% and less than 0.01%.

3. The pharmaceutical composition of claim 2, wherein said tropicamide is present at a concentration of at least 0.005% and less than 0.01%.

4. The pharmaceutical composition of claim 2, wherein said tropicamide is present at a concentration of between 0.0025% and 0.005%.