Treatment and prevention of Alzheimer's disease (AD)
Inventors
Mandler, Markus • Schneeberger, Achim • Zauner, Wolfgang • Von Bonin, Arne • Mattner, Frank • Schmidt, Walter
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11857568-B2
Publication Date
2024-01-02
Expiration Date
Abstract
The invention discloses an aluminium salt for use in the treatment and prevention of dementias associated with β-amyloid deposition, preferably AD.
Core Innovation
The invention relates to treating and preventing β-amyloid deposition dementias, especially Alzheimer’s disease (AD), by administering an aluminium salt, preferably an aluminium oxyhydroxide (Alhydrogel/Alum), to a patient. The core approach emphasizes a disease-modifying effect in early AD and is connected to amyloid-β (Aβ40, Aβ42) deposition outcomes and related dementia treatment goals.
The described problem is the occurrence and progression of β-amyloid deposition dementias, including cognitive decline and associated structural and functional deterioration. The background framing indicates a need for treatment and prevention approaches that can slow decline and produce measurable changes using clinical and biomarker measures.
In the disclosed clinical context, efficacy is reflected by slowed decline relative to historical controls and by changes in structural MRI biomarker findings, including right hippocampus volume and hippocampal atrophy. Caregiver-reported QOL improvements are also described alongside clinical composite scores, and the approach is further associated with correlations to reported efficacy outcomes.
Supporting data described in the document include Tg2576 (APP-transgenic mouse model) findings showing cognitive benefit from topical/immune-independent Alum effects without significant cerebral Aβ-deposition changes, which is presented as consistent with an APP/Aβ-independent mechanism.
Claims Coverage
The provided claim set indicates one independent claim covering treatment of mild cognitive impairment (MCI) using a pharmaceutical formulation with a specific scope of an aluminum salt as the sole active pharmaceutical ingredient in a defined amount range. Additional refinements specify dosing frequency/range, diagnostic selection, and formulation constraints.
Aluminum-salt-only formulation for MCI treatment
A method for treating mild cognitive impairment (MCI) comprising administering to a patient diagnosed with an MCI a pharmaceutical formulation comprising a sole active pharmaceutical ingredient, wherein the sole active pharmaceutical ingredient is an aluminum salt in an amount from about 1.0 mg to about 3.0 mg.
Monthly single-dose aluminum-salt administration within a defined range
Administering the aluminum salt to the patient at least once monthly in a single administration dose of from about 1.5 mg to about 3.0 mg.
Specified anion and heavy-metal impurity constraints
Using a pharmaceutical formulation that is substantially devoid of sulfate, nitrate, or chloride anions and has a heavy metal content of less than 20 ppm.
Aluminium oxyhydroxide suspension with defined particle size distribution
Using an aluminium oxyhydroxide suspension whose particle size distribution is between about 2 μm and about 10 μm.
Diagnostic selection of MCI based on defined clinical and biomarker features
Further comprising diagnosing the patient with the MCI based on identifying the patient as having at least one feature selected from medial temporal lobe atrophy, temporoparietal cortical hypometabolism, abnormality of cerebrospinal fluid markers comprising tau, amyloid-β42 or phosphorylated-tau, and positivity on amyloid in the patient.
The main inventive coverage is treatment of MCI by administering a pharmaceutical formulation in which the sole active pharmaceutical ingredient is an aluminum salt in a defined mg range, with further refinements to dosing frequency and single-dose range, formulation impurity/anion constraints, aluminium oxyhydroxide suspension particle size distribution, and diagnostic selection based on specified anatomical and biomarker features.
Stated Advantages
Disease-modifying effects in early Alzheimer’s disease (AD), including slowed decline versus historical controls.
Structural MRI biomarker changes, including right hippocampus volume and hippocampal atrophy.
Caregiver-reported QOL improvements.
Cognitive benefit observed in Tg2576 with topical/immune-independent Alum effects without significant cerebral Aβ-deposition changes, consistent with an APP/Aβ-independent mechanism.
Documented Applications
Treating mild cognitive impairment (MCI) in a patient by administering a pharmaceutical formulation having a sole active pharmaceutical ingredient that is an aluminum salt.
Diagnosing MCI based on at least one selected feature (medial temporal lobe atrophy, temporoparietal cortical hypometabolism, cerebrospinal fluid markers comprising tau, amyloid-β42 or phosphorylated-tau, and positivity on amyloid) to support MCI treatment using the aluminium-salt formulation.
Treating and preventing β-amyloid deposition dementias, especially Alzheimer’s disease (AD), using an aluminium salt, preferably aluminium oxyhydroxide (Alhydrogel/Alum).
Interested in licensing this patent?