Devices, systems and methods for screening for alzheimer's disease by detecting a differential in olfactory identification for pure odorants

Abstract

The present system is directed in various embodiments to devices, systems and methods for detection, evaluation and/or monitoring olfactory dysfunction by measuring and determining the patient's olfactory detection threshold for the left and the right nostril. More specifically, the present invention relates to devices, systems and methods for detecting an asymmetric differential in a patient's olfactory detection threshold (left vs right nostril) which, when present, may be used as a tool to screen, detect, diagnose and/or monitor relative olfactory deterioration resulting from Alzheimer's disease. A preferred embodiment comprises cascading aromas by serially administering more than one pure odorant to the patient's nostrils, left vs right, with measurement of the time, or numbers of breaths, required to cognitively notice the pure odorants' presence.

What is claimed is: 
     
         1 . A method for assessing deterioration and/or damage to the left olfactory lobe of a patient relative to the patient's right olfactory lobe, by measuring the relative sensitivities of the left and right olfactory bulbs to at least one pure odorant, each pure odorant comprising a substance that only stimulates the first cranial nerve and not the 5 th  cranial nerve, the method comprising:
 providing at least one pure odorant, the at least one pure odorant capable of stimulating the first cranial nerve and not the 5 th  cranial nerve;   establishing an introduction order for the at least one pure odorant;   introducing pure odorant-infused air in the established introduction order to the patient's first nostril;   measuring and recording a pure odorant identification response metric for each introduction of the pure odorant-infused air in the established introduction order, the pure odorant identification response metric comprising the patient's identification of the pure odorant in the pure odorant-infused air indicating the patient reached a pure odorant identification threshold with the first nostril for the at least one pure odorant and, if more than one pure odorant is present in the established introduction order, switching from a first pure odorant in the established introduction order to the next pure odorant in the established introduction order after the patient reaches the pure odorant identification threshold for the first pure odorant and repeating the measuring and recording steps for the next pure odorant in the established introduction order;   introducing pure odorant-infused air in the established introduction order to the patient's second nostril;   measuring and recording a pure odorant identification response metric for each introduction of the pure odorant-infused air introduction, the pure odorant identification response metric comprising the patient's identification of the introduced pure odorant indicating the patient reached a pure odorant identification threshold with the second nostril for the at least one pure odorant and, if more than one pure odorant is present in the established introduction order, switching from a first pure odorant in the established introduction order to the next pure odorant in the established introduction order after the patient reaches the pure odorant identification threshold for the first pure odorant and repeating the measuring and recording steps for the next pure odorant in the established introduction order;   comparing the recorded and correctly identified pure odorant identification response metrics for the first nostril and the second nostril to obtain a relative pure odorant identification threshold value for each nostril; and   determining whether the obtained relative pure odorant identification threshold value for the first nostril is statistically different from the obtained relative pure odorant identification threshold for the second nostril.   
     
     
         2 . The method of  claim 1 , further comprising concluding that, if the patient's pure odorant identification threshold value for the patient's left nostril is statistically higher with a statistically lower number of correct responses as compared with the pure odorant identification threshold value for the patient's right nostril, the patient's left olfactory lobe comprises deterioration and/or damage that is not detected in the right olfactory lobe. 
     
     
         3 . The method of  claim 2 , wherein the deterioration and/or damage is a result of Alzheimer's disease. 
     
     
         4 . The method of  claim 1 , wherein the pure odorant identification response metric comprises selection of the pure odorant in the pure-odorant infused air from a multiple choice selection of pure odorants. 
     
     
         5 . The method of  claim 1 , wherein the at least one pure odorant comprises at least one essential oil. 
     
     
         6 . The method of  claim 1 , wherein the at least one essential oils is an essential oil of a named plant. 
     
     
         7 . The method of  1 , further comprising providing a device comprising:
 a housing, the housing comprising:
 a dedicated clear airway passage defined within the housing and in fluid communication with a clear air source; 
 a dedicated active pure odorant airway passage defined within the housing, the pure odorant airway passage separated from and not in fluid communication with the clear airway passage; 
 a first nasal tip having a lumen therethrough and in dedicated fluid communication with the clear airway passage; 
 a second nasal tip having a lumen therethrough and in dedicated fluid communication with the active pure odorant airway passage; and 
 a pure odorant cartridge comprising a substantially circular rigid body and having two sides, further comprising a plurality of pure odorant chambers defined by the rigid body, each chamber adapted to hold one of the at least one pure odorants and arranged sequentially in the established introduction order, and the cartridge being rotatably disposed in the housing, wherein the sequentially arranged pure odorant chambers are successively rotatably aligned to enable a selected pure odorant chamber to move into fluid communication with the dedicated pure odorant airway passage and the first nasal tip, wherein the pure odorant compartment and the pure odorant located therein are in fluid communication with the pure odorant airway passage and not in fluid communication with the clear airway passage; 
 introducing pure odorant-infused air into the pure odorant airway passage for a first pure odorant in the established introduction order for the first nostril at the first nasal tip and clear air into the clear airway passage at the second nasal tip; 
 measuring and recording the pure odorant identification metric patient response for the pure odorant-infused air introduction; 
 switching from the first pure odorant in the established introduction order to the next pure odorant in the established introduction order after the patient reaches the pure odorant identification threshold for the first pure odorant and repeating the measuring and recording steps for the next pure odorant in the established introduction order; 
 repeating the switching, measuring and recording steps for each remaining pure odorant and the first nostril in the established introduction order; 
 rotating the device 180 degrees to align the first nasal tip and the pure odorant airway passage with the patient's second nostril, and the second nasal tip aligned with the clear airway passage with the patient's first nostril; 
 introducing pure odorant-infused air into the pure odorant airway passage for a first pure odorant in the established introduction order for the second nostril at the first nasal tip and introducing clear air into the clear airway passage at the second nasal tip; 
 measuring and recording the pure odorant identification metric patient response for the pure odorant-infused air introduction; 
 switching from the first pure odorant in the established introduction order to the next pure odorant in the established introduction order after the patient reaches the pure odorant identification threshold for the first pure odorant and repeating the measuring and recording steps for the next pure odorant in the established introduction order; and 
 repeating the switching, measuring and recording steps for each remaining pure odorant and the second nostril in the established introduction order. 
   
     
     
         8 . The method of  claim 7 , wherein the introducing of pure odorant air into the dedicated pure odorant airway passage from the pure odorant chamber is achieved solely by force of the patient's inhalation through the first nasal tip. 
     
     
         9 . The method of  claim 7 , wherein each pure odorant chamber in the pure odorant cartridge further comprises an indexing indicia associated with the pure odorant located therein. 
     
     
         10 . The method of  claim 9 , further comprising providing a separate key matching the indexing indicia. 
     
     
         11 . The method of  claim 10 , further comprising using the key to annunciate each pure odorant chamber and pure odorant located therein, when each pure odorant chamber is aligned with the dedicated pure odorant airway passage. 
     
     
         12 . The method of  claim 1 , wherein the switching from a first pure odorant to the next pure odorant in the established introduction order after the patient reaches the pure odorant identification threshold for the first pure odorant further comprises no reset period. 
     
     
         13 . The method of  claim 7 , wherein the switching from a first pure odorant to the next pure odorant in the established introduction order after the patient reaches the pure odorant identification threshold is done manually by actuating a rotation of the pure odorant cartridge to align the next pure odorant chamber in the cartridge with the dedicated pure odorant airway passage. 
     
     
         14 . The method of  claim 1 , further comprising providing a programmable computing device comprising:
 a memory adapted to store programmed instructions for the programmable computing device and for results of the method;   a processor in operative connection with the memory and adapted to execute the stored programmed instructions;   an input device in operative communication with the processor and memory and adapted to input patient responses and initiate the stored programmed instructions; and   a display in operative communication with the memory, processor and input device;   wherein the programmable computing device is selected from one or more of the group consisting of a smartphone, an iPad, a personal computer, and a server and wherein the multiple choice selection of pure odorants is displayed on the display, the selection of the pure odorant from the multiple choice selection is achieved with the input device and stored within the memory.   
     
     
         15 . The method of  claim 14 , wherein the programmable computing device is programmed to:
 identify the correctly identified multiple choice responses for the first and for the second nostril;   compare the correctly identified multiple choice responses for the first nostril and the second nostril to obtain a relative pure odorant identification threshold value for each nostril; and   determine whether the obtained relative pure odorant identification threshold value for the first nostril is statistically higher, lower or equivalent with the relative pure odorant identification threshold for the second nostril.   
     
     
         16 . The method of  claim 15 , the programmable computing device further programmed to determine that if the patient's relative pure odorant identification threshold value for the patient's left nostril is not statistically higher and comprises a statistically equivalent number of correct responses as compared with the relative pure odorant identification threshold value for the patient's right nostril, the patient is then ruled out for the left olfactory damage and/or deterioration, since the left and right olfactory bulbs have sensitivities to pure odorants that are statistically equivalent. 
     
     
         17 . The method of  claim 16 , further comprising the programmable computing device generating a report summarizing the relative pure odorant identification threshold values for the patient's right and left nostrils. 
     
     
         18 . The method of  claim 15 , the programmable computing device further programmed to determine that if the patient's relative pure odorant identification threshold value for the patient's left nostril is statistically higher and comprises a statistically lower number of correct responses as compared with the relative pure odorant identification threshold value for the patient's right nostril, the patient is identified as having left olfactory damage and/or deterioration, since the left and right olfactory bulbs have sensitivities to pure odorants that are not statistically equivalent. 
     
     
         19 . The method of  claim 18 , further comprising the programmable computing device generating a report summarizing the relative pure odorant identification threshold values for the patient's right and left nostrils. 
     
     
         20 . The method of  claim 1 , wherein the first nostril comprises the patient's right nostril. 
     
     
         21 . A method for screening for Alzheimer's disease in a patient by measuring the relative sensitivities of the left and right olfactory bulbs to substances that only stimulate the first cranial nerve and not the 5 th  cranial nerve, comprising:
 providing at least one pure odorant, the at least one pure odorant capable of stimulating the first cranial nerve and not the 5 th  cranial nerve;   establishing an introduction order for the at least one pure odorant;   introducing pure odorant-infused air in the established introduction order to the patient's first nostril;   measuring and recording a pure odorant identification response metric for the pure odorant-infused air introduction, the pure odorant identification metric comprising the patient's identification of the introduced pure odorant indicating the patient reached a pure odorant identification threshold with the first nostril for the at least one pure odorant and, if more than one pure odorant is present in the established introduction order, switching from a first pure odorant in the established introduction order to the next pure odorant in the established introduction order after the patient reaches the pure odorant identification threshold for the first pure odorant and repeating the measuring and recording steps for the next pure odorant in the established introduction order;   introducing pure odorant-infused air in the established introduction order to the patient's second nostril;   measuring and recording a pure odorant identification response metric for each introduction of the pure odorant-infused air introduction, the pure odorant identification metric comprising the patient's identification of the introduced pure odorant indicating the patient reached a pure odorant identification threshold with the second nostril for the at least one pure odorant and, if more than one pure odorant is present in the established introduction order, switching from a first pure odorant in the established introduction order to the next pure odorant in the established introduction order after the patient reaches the pure odorant identification threshold for the first pure odorant and repeating the measuring and recording steps for the next pure odorant in the established introduction order;   comparing the recorded and correctly identified pure odorant identification response metrics for the first nostril and the second nostril to obtain a relative pure odorant identification threshold value for each nostril;   determining whether the obtained relative pure odorant identification threshold value for the first nostril is statistically different from the obtained relative pure odorant identification threshold for the second nostril; and   concluding that, if the patient's relative pure odorant identification threshold value for the patient's left nostril is not statistically higher and comprises a statistically equivalent number of correct responses as compared with the relative pure odorant identification threshold value for the patient's right nostril, the patient is ruled out for the presence of Alzheimer's disease, since the left and right olfactory bulbs have sensitivities to pure odorants that are statistically equivalent and therefore not consistent with Alzheimer's disease.   
     
     
         22 . The method of  claim 1 , the pure odorant identification response metric further comprising providing a multiple choice selection for each of the at least one pure odorant and requiring the patient to select one of the multiple choice selections upon reaching the pure odorant identification threshold, wherein the relative pure odorant identification threshold value comprises the total number of correct identification responses. 
     
     
         23 . The method of  claim 21 , wherein the pure odorant identification response metric comprises selection of the pure odorant in the pure-odorant infused air from a multiple choice selection of pure odorants. 
     
     
         24 . The method of  claim 21 , wherein the at least one pure odorant comprises at least one essential oil of a named plant. 
     
     
         25 . The method of  21 , further comprising providing a device comprising:
 a housing, the housing comprising:
 a dedicated clear airway passage defined within the housing and in fluid communication with a clear air source; 
 a dedicated active pure odorant airway passage defined within the housing, the pure odorant airway passage separated from and not in fluid communication with the clear airway passage; 
 a first nasal tip having a lumen therethrough and in dedicated fluid communication with the clear airway passage; 
 a second nasal tip having a lumen therethrough and in dedicated fluid communication with the active pure odorant airway passage; and 
 a pure odorant cartridge comprising a substantially circular rigid body and having two sides, further comprising a plurality of pure odorant chambers defined by the rigid body, each chamber adapted to hold one of the at least one pure odorants and arranged sequentially in the established introduction order, and the cartridge being rotatably disposed in the housing, wherein the sequentially arranged pure odorant chambers are successively rotatably aligned to enable a selected pure odorant chamber to move into fluid communication with the dedicated pure odorant airway passage and the first nasal tip, wherein the pure odorant compartment and the pure odorant located therein are in fluid communication with the pure odorant airway passage and not in fluid communication with the clear airway passage; 
 introducing pure odorant-infused air into the pure odorant airway passage for a first pure odorant in the established introduction order for the first nostril at the first nasal tip and clear air into the clear airway passage at the second nasal tip; 
 measuring and recording the pure odorant identification metric patient response for the pure odorant-infused air introduction; 
 switching from the first pure odorant in the established introduction order to the next pure odorant in the established introduction order after the patient reaches the pure odorant identification threshold for the first pure odorant and repeating the measuring and recording steps for the next pure odorant in the established introduction order; 
 repeating the switching, measuring and recording steps for each remaining pure odorant and the first nostril in the established introduction order; 
 rotating the device 180 degrees to align the first nasal tip and the pure odorant airway passage with the patient's second nostril, and the second nasal tip aligned with the clear airway passage with the patient's first nostril; 
 introducing pure odorant-infused air into the pure odorant airway passage for a first pure odorant in the established introduction order for the second nostril at the first nasal tip and introducing clear air into the clear airway passage at the second nasal tip; 
 measuring and recording the pure odorant identification metric patient response for the pure odorant-infused air introduction; 
 switching from the first pure odorant in the established introduction order to the next pure odorant in the established introduction order after the patient reaches the pure odorant identification threshold for the first pure odorant and repeating the measuring and recording steps for the next pure odorant in the established introduction order; and 
 repeating the switching, measuring and recording steps for each remaining pure odorant and the second nostril in the established introduction order. 
   
     
     
         26 . The method of  claim 25 , wherein the introducing of pure odorant air into the dedicated pure odorant airway passage from the pure odorant chamber is achieved solely by force of the patient's inhalation through the first nasal tip. 
     
     
         27 . The method of  claim 25 , wherein each pure odorant chamber in the pure odorant cartridge further comprises an indexing indicia associated with the pure odorant located therein. 
     
     
         28 . The method of  claim 27 , further comprising providing a separate key matching the indexing indicia. 
     
     
         29 . The method of  claim 28 , further comprising using the key to annunciate each pure odorant chamber and pure odorant located therein, when each pure odorant chamber is aligned with the dedicated pure odorant airway passage. 
     
     
         30 . The method of  claim 21 , wherein the switching from a first pure odorant to the next pure odorant in the established introduction order after the patient reaches the pure odorant identification threshold for the first pure odorant further comprises no reset period. 
     
     
         31 . The method of  claim 25 , wherein the switching from a first pure odorant to the next pure odorant in the established introduction order after the patient reaches the pure odorant identification threshold is done manually by actuating a rotation of the pure odorant cartridge to align the next pure odorant chamber in the cartridge with the dedicated pure odorant airway passage. 
     
     
         32 . The method of  claim 21 , further comprising providing a programmable computing device comprising:
 a memory adapted to store programmed instructions for the programmable computing device and for results of the method;   a processor in operative connection with the memory and adapted to execute the stored programmed instructions;   an input device in operative communication with the processor and memory and adapted to input patient responses and initiate the stored programmed instructions; and   a display in operative communication with the memory, processor and input device;   wherein the programmable computing device is selected from one or more of the group consisting of a smartphone, an iPad, a personal computer, and a server and wherein the multiple choice selection of pure odorants is displayed on the display, the selection of the pure odorant from the multiple choice selection is achieved with the input device and stored within the memory.   
     
     
         33 . The method of  claim 32 , wherein the programmable computing device is programmed to:
 identify the correctly identified multiple choice responses for the first and for the second nostril;   compare the correctly identified multiple choice responses for the first nostril and the second nostril to obtain a relative pure odorant identification threshold value for each nostril; and   determine whether the obtained relative pure odorant identification threshold value for the first nostril is statistically higher, lower or equivalent with the relative pure odorant identification threshold for the second nostril.   
     
     
         34 . The method of  claim 33 , the programmable computing device further programmed to determine that if the patient's relative pure odorant identification threshold value for the patient's left nostril is not statistically higher and comprises a statistically equivalent number of correct responses as compared with the relative pure odorant identification threshold value for the patient's right nostril, the patient is then ruled out for the left olfactory damage and/or deterioration, since the left and right olfactory bulbs have sensitivities to pure odorants that are statistically equivalent. 
     
     
         35 . The method of  claim 34 , further comprising the programmable computing device generating a report summarizing the relative pure odorant identification threshold values for the patient's right and left nostrils. 
     
     
         36 . The method of  claim 33 , the programmable computing device further programmed to determine that if the patient's relative pure odorant identification threshold value for the patient's left nostril is statistically higher and comprises a statistically lower number of correct responses as compared with the relative pure odorant identification threshold value for the patient's right nostril, the patient is identified as having left olfactory damage and/or deterioration, since the left and right olfactory bulbs have sensitivities to pure odorants that are not statistically equivalent. 
     
     
         37 . The method of  claim 36 , further comprising the programmable computing device generating a report summarizing the relative pure odorant identification threshold values for the patient's right and left nostrils. 
     
     
         38 . The method of  claim 21 , wherein the first nostril comprises the patient's right nostril.