Acetyl-leucine or a pharmaceutically acceptable salt thereof for improved mobility and cognitive function
Inventors
Factor, Mallory • Strupp, Michael
Assignees
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Publication Number
US-11998518-B2
Publication Date
2024-06-04
Expiration Date
Abstract
The present disclosure is directed to acetyl-leucine or a pharmaceutically acceptable salt thereof for use in improving cognitive function, mobility, or cognitive function and mobility in a subject, for example, in an elderly subject.
Core Innovation
The invention relates to methods of treating age-associated decreases in cognitive function in a subject in need thereof by identifying a subject with the decrease, taking a baseline measurement of cognitive function using one or more tests, administering a therapeutically effective amount of acetyl-leucine or a pharmaceutically acceptable salt, and then measuring and comparing cognitive function after treatment to determine improvement. The subject does not have vertigo or a neurological or neurodegenerative disease, disorder, or condition.
A further aspect of the invention treats improvement in reaction speed and alertness as a direct consequence of ageing by identifying a subject with no apparent dysfunction in cognitive ability, movement, or balance, while still needing improvement in reaction speed, alertness, or both. The method includes baseline measurement using one or more tests, administration of acetyl-leucine or a pharmaceutically acceptable salt for a treatment duration, and post-treatment measurement and comparison to determine improvement in reaction speed and/or alertness.
Another aspect of the invention treats gait disorder associated with ageing, postural imbalance associated with ageing, and/or impaired spatial orientation associated with ageing by identifying an affected subject, taking baseline measurements using one or more tests, administering acetyl-leucine or a pharmaceutically acceptable salt for a treatment duration, and then measuring and comparing after treatment to determine improvement in gait disorder, postural imbalance, and/or impaired spatial orientation. The treated subject excludes those with vertigo and those with a neurological or neurodegenerative disease, disorder, or condition.
Claims Coverage
The independent claims comprise three inventive methods that each follow a baseline-measurement, acetyl-leucine administration for a treatment duration, and post-treatment measurement with comparison-to-baseline framework, while defining different ageing-related outcomes to improve. Across the independent claims, the exclusion condition that the subject does not have vertigo or a neurological or neurodegenerative disease, disorder, or condition is also included.
Treating age-associated cognitive function decrease with baseline measurement and acetyl-leucine
A method comprising identifying a subject having the decrease in cognitive function associated with ageing; taking a baseline measurement of the subject's cognitive function using one or more tests; administering a therapeutically effective amount of acetyl-leucine or a pharmaceutically acceptable salt thereof to the subject for a treatment duration; measuring the subject's cognitive function using the one or more tests after the subject is treated; and comparing the subject's cognitive function after treatment to the baseline measurement to determine if there is an improvement in the subject's cognitive function, wherein the subject does not have vertigo or a neurological or neurodegenerative disease, disorder, or condition.
Improving reaction speed and alertness as a direct consequence of ageing using baseline measurement and acetyl-leucine
A method comprising identifying the subject with no apparent dysfunction in cognitive ability, movement, or balance, but in need of improvement in reaction speed, alertness, or both reaction speed and alertness, which are a direct consequence of ageing of the subject; taking a baseline measurement of the subject's reaction speed, alertness, or both reaction speed and alertness using one or more tests; administering a therapeutically effective amount of acetyl-leucine or a pharmaceutically acceptable salt thereof to the subject for a treatment duration; measuring reaction speed, alertness, or both reaction speed and alertness after the subject is treated; and comparing the subject's reaction speed, alertness, or both reaction speed and alertness after treatment compared to the baseline measurement to determine if there has been an improvement in reaction speed, alertness, or both reaction speed and alertness in the subject, wherein the subject does not have vertigo or a neurological or neurodegenerative disease, disorder, or condition.
Treating gait disorder, postural imbalance, and impaired spatial orientation associated with ageing using baseline measurement and acetyl-leucine
A method comprising identifying the subject having gait disorder, postural imbalance, and/or impaired spatial orientation associated with ageing in the subject; taking a baseline measurement of the subject's gait disorder, postural imbalance, and/or impaired spatial orientation using one or more tests; administering a therapeutically effective amount of acetyl-leucine or a pharmaceutically acceptable salt thereof to the subject for a treatment duration; measuring the subject's gait disorder, postural imbalance, and/or impaired spatial orientation after the subject is treated; and comparing the subject's gait disorder, postural imbalance, and/or impaired spatial orientation after treatment to the baseline measurement to determine if there is an improvement in the subject's gait disorder, postural imbalance, and/or impaired spatial orientation.
The independent claims cover three acetyl-leucine treatment frameworks for ageing-associated outcomes: improvement of cognitive function decrease, improvement in reaction speed and/or alertness, and improvement in gait disorder, postural imbalance, and/or impaired spatial orientation. Each framework requires baseline measurement, administration of acetyl-leucine or a pharmaceutically acceptable salt for a treatment duration, and comparison after treatment, with the subject exclusion of vertigo and neurological or neurodegenerative disease, disorder, or condition.
Stated Advantages
Improvement in the subject's cognitive function after treatment compared to baseline.
Improvement in reaction speed, alertness, or both after treatment compared to baseline.
Improvement in gait disorder, postural imbalance, and/or impaired spatial orientation after treatment compared to baseline.
Documented Applications
Treating a decrease in cognitive function associated with ageing in a subject in need thereof, excluding subjects with vertigo and neurological or neurodegenerative disease, disorder, or condition.
Treating improvement needs in reaction speed and/or alertness as a result of ageing, for subjects without apparent dysfunction in cognitive ability, movement, or balance, and excluding subjects with vertigo and neurological or neurodegenerative disease, disorder, or condition.
Treating gait disorder associated with ageing, postural imbalance associated with ageing, and/or impaired spatial orientation associated with ageing by administering acetyl-leucine or a pharmaceutically acceptable salt and assessing improvement versus baseline.
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