Treatment of Alzheimer's Disease (AD) with an aluminum salt
Inventors
Mandler, Markus • Schneeberger, Achim • Mattner, Frank • Schmidt, Walter
Assignees
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Publication Number
US-11147873-B2
Publication Date
2021-10-19
Expiration Date
Abstract
Disclosed is a method for the treatment of AD, wherein an immune stimulating pharmaceutical composition comprising an aluminium salt is administered to a patient having AD or having a risk to develop AD in an effective amount.
Core Innovation
The disclosure relates to immune stimulating aluminium-salt pharmaceutical compositions for treating or preventing Alzheimer’s disease (AD). The method administers an effective amount of at least one immune stimulating pharmaceutical composition comprising an aluminium salt to a patient having AD or having a risk of developing AD.
The immune stimulating pharmaceutical composition uses aluminium salt as the single effective ingredient, with an aluminium-salt amount administered in the range of 1.2 mg to 5.0 mg. The disclosure emphasizes aluminium-salt clinical benefit in AD, including disease-modifying clinical outcomes supported by cognitive/functional endpoints and structural neuroimaging effects.
The disclosure also describes rationale linking neuroinflammation and immunotherapy to AD, including preclinical work using a Tg2576 mouse model. The reported preclinical findings indicate that alum/topical aluminium-oxyhydroxide can improve learning/memory while not significantly changing cerebral Aβ load, consistent with an Aβ/APP-independent mechanism.
Claims Coverage
The independent claim covers a method for treating AD by administering an immune stimulating pharmaceutical composition comprising an aluminium salt, with the aluminium salt being the single effective ingredient administered in an amount of 1.2 mg to 5.0 mg. The dependent claims refine the independent claim by specifying aluminium salt forms and preparation constraints, and by narrowing administration routes and dosing/regimen parameters.
Immune stimulating aluminium-salt treatment of Alzheimer’s disease
Administering an effective amount of at least one immune stimulating pharmaceutical composition comprising an aluminium salt to a patient having AD or having a risk of developing AD.
Aluminium salt as the single effective ingredient dose range
Administering the aluminium salt as the single effective ingredient in said immune stimulating pharmaceutical composition in an amount of 1.2 mg to 5.0 mg.
Aluminium oxyhydroxide administration routes
Administering aluminium oxyhydroxide to an AD patient via subcutaneous, intranodal, intradermal, or intramuscular routes.
At least monthly dosing for at least two years
Administering aluminium oxyhydroxide to an AD patient at least monthly for at least two years.
Liquid dosing volume range
Administering aluminium oxyhydroxide in liquid form with an application volume of 0.1 to 10 ml.
Anion-free, low heavy metal suspension with specified particle/aggregate/fiber sizes
A pharmaceutical preparation that is sulfate-, nitrate-, and chloride-anion-free, having heavy metal content less than 20 ppm, and being a suspension of aluminium oxyhydroxide with a particle size distribution between about 2 µm and about 10 µm composed of aggregates made of smaller fibers sized about 2 nm×4.5 nm×10 nm.
Overall, the claim set centers on treating AD using an immune stimulating aluminium-salt pharmaceutical composition where aluminium salt is the single effective ingredient in a specified 1.2 mg to 5.0 mg range, with dependent claims narrowing to aluminium oxyhydroxide embodiments, specific administration routes, dosing frequency/duration, liquid application volume, and defined pharmaceutical preparation constraints including anion-free composition, heavy metal limits, and multi-level particle/aggregate/fiber size specifications.
Stated Advantages
Disease-modifying clinical outcomes in Alzheimer’s disease supported by composite cognitive/functional measures.
Statistically significant MRI structural biomarker effects, including correlation with right hippocampus volume and hippocampal atrophy.
Improvement in learning/memory in preclinical Tg2576 experiments.
Reported not significantly changing cerebral Aβ load, consistent with an Aβ/APP-independent mechanism.
Documented Applications
Treating Alzheimer’s disease (AD) in a patient having AD.
Treating or addressing risk of developing Alzheimer’s disease (AD) in a patient having a risk of developing AD.
A clinical trial AFF006 in early AD (including mild cognitive impairment) using aluminium (1 mg vs 2 mg aluminium) with slowed progression via composite cognitive/functional measures and MRI effects.
Preclinical Tg2576 mouse experiments assessing learning/memory (contextual fear conditioning) and cerebral Aβ load.
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