US2023028607A1PendingUtilityA1

Compositions and methods that attenuate cognitive aging in individuals who do not have dementia

Assignee: NESTLE SAPriority: Apr 11, 2017Filed: Oct 6, 2022Published: Jan 26, 2023
Est. expiryApr 11, 2037(~10.7 yrs left)· nominal 20-yr term from priority
A61K 31/593A61P 25/28G01N 33/6896G01N 33/82G01N 2800/2821A61K 31/198A61K 31/592A61K 31/202A61K 31/714A61K 31/14A61K 31/7068A61K 31/51A61K 31/4415
72
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Claims

Abstract

A method of attenuating, treating or preventing cognitive aging in an individual who does not have dementia includes administering to the individual a therapeutically effective amount of a composition containing an omega-3 fatty acid, a nitric oxide releasing compound, Vitamin B12 and choline. The composition is administered in a daily dose that provides 0.1 to 50 times the recommended daily requirement (RDA) of Vitamin B12 per day, more preferably 0.1 to 40 times the recommended daily requirement (RDA) of Vitamin B12 per day and 0.01 to 10.0 times the recommended daily requirement (RDA) of choline. Optionally Vitamin B6 and/or Vitamin B9 can be included in the composition. The method can achieve a benefit that is one or more of decreasing brain atrophy, increasing or maintaining number of synapses, increasing amyloid-β phagocytosis, or decreasing or maintaining neuroinflammation in the non-demented individual. The method can prevent dementia in an individual at risk thereof, for example an elderly human.

Claims

exact text as granted — not AI-modified
1 . A method of attenuating, treating or preventing cognitive aging in a non-demented individual in need thereof or at risk thereof, the method comprising administering to the non-demented individual a therapeutically effective amount of a composition comprising eicosapentaenoic acid (EPA), a nitric oxide releasing compound, Vitamin B 12, and choline. 
     
     
         2 . The method of  claim 1 , wherein the composition is administered in a daily dose that comprises 0.5 g/day to 1.0 g/day of the EPA and 2.0 to 10.0 times the recommended daily requirement (RDA) of choline, and the non-demented individual has a risk score in Cardiovascular Risk Factors, Aging and Dementia (CAIDE) of 10 to 15 at baseline. 
     
     
         3 . The method of  claim 2 , wherein the daily dose comprises 0.1 to 50 times the recommended daily requirement (RDA) of Vitamin B12 per day. 
     
     
         4 . (canceled) 
     
     
         5 . The method of  claim 1 , wherein the non-demented individual is an older adult or a companion animal. 
     
     
         6 . (canceled) 
     
     
         7 . The method of  claim 1 , wherein the composition is orally administered to the non-demented individual daily for at least one month. 
     
     
         8 . The method of  claim 1 , wherein the nitric oxide releasing compound comprises citrulline. 
     
     
         9 . The method of  claim 1 , wherein the composition further comprises docosahexaenoic acid. 
     
     
         10 . The method of  claim 1 , wherein the composition comprises one or more additional B vitamins selected from the group consisting of Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B7 and Vitamin B9. 
     
     
         11 . The method of  claim 1 , wherein the composition comprises one or more further antioxidants selected from the group consisting of Vitamin C, Vitamin D, Vitamin E, and selenium. 
     
     
         12 . The method of  claim 1 , wherein the non-demented individual has a low DHA status at baseline. 
     
     
         13 . The method of  claim 1 , wherein the non-demented individual has a Clinical Dementia Rating (CDR) of 0.5 at baseline. 
     
     
         14 . The method of  claim 1 , wherein the non-demented individual has a low a plasma homocysteine level at baseline of at least 12 µmol/L. 
     
     
         15 . A method of improving cognitive ability in a non-demented individual in need thereof, the method comprising administering to the non-demented individual a therapeutically effective amount of a composition comprising eicosapentaenoic acid (EPA), a nitric oxide releasing compound, Vitamin B12, and choline. 
     
     
         16 . The method of  claim 15 , wherein the composition is administered in a daily dose that comprises 0.5 g/day to 1.0 g/day of the EPA and 2.0 to 10.0 times the recommended daily requirement (RDA) of choline, and the non-demented individual has a risk score in Cardiovascular Risk Factors, Aging and Dementia (CAIDE) of 10 to 15 at baseline. 
     
     
         17 . The method of  claim 16 , wherein the daily dose comprises 0.1 to 40 times the recommended daily requirement (RDA) of Vitamin B12 per day. 
     
     
         18 . A method of achieving one or more of benefits selected from the group consisting of decreasing brain atrophy, increasing or maintaining number of synapses, increasing or maintaining amyloid-β phagocytosis, and decreasing neuroinflammation in a non-demented individual in need thereof, the method comprising administering to the non-demented individual a therapeutically effective amount of a composition comprising eicosapentaenoic acid (EPA), a nitric oxide releasing compound, Vitamin B12, and choline. 
     
     
         19 . The method of  claim 18 , wherein the composition is administered in a daily dose that comprises 0.5 g/day to 1.0 g/day of the EPA and 2.0 to 10.0 times the recommended daily requirement (RDA) of choline, and the non-demented individual has a risk score in Cardiovascular Risk Factors, Aging and Dementia (CAIDE) of 10 to 15 at baseline. 
     
     
         20 . The method of  claim 19 , wherein the daily dose comprises 0.1 to 50 times the recommended daily requirement (RDA) of Vitamin B12 per day and 0.01 to 10.0 times the recommended daily requirement (RDA) of choline. 
     
     
         21 . (canceled) 
     
     
         22 . The method of  claim 18 , wherein the nitric oxide releasing compound comprises citrulline, and the composition further comprises docosahexaenoic acid. 
     
     
         23 . The method of  claim 1 , wherein the composition comprises magnesium. 
     
     
         24 . The method of  claim 15 , wherein the composition comprises magnesium. 
     
     
         25 . The method of  claim 18 , wherein the composition comprises magnesium.

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