In short
Clinical trials investigating Aluminium Hydroxide are studying how it is used in research settings, mainly as part of allergy testing and treatment studies, and as a trial ingredient in other intervention plans. These studies look at safety, efficacy, and measured outcomes in specific patient groups such as adults with allergic rhinitis or people with early Alzheimer’s disease.
Key points
- Clinical trials involving Aluminium Hydroxide in the provided data are focused on two very different conditions. One Phase 3 study in adults with moderate to severe house dust mite allergy-related rhinitis or rhinoconjunctivitis was completed and measured daily symptom scores. Another Phase 2 study in early Alzheimer’s disease was suspended and looked at combined thinking, daily function, and global change over 6 months. The allergy study enrolled 582 participants, while the Alzheimer’s study enrolled 58. The data shows that Aluminium Hydroxide appears in the allergy trial as one of several study-related interventions. Overall, the trials are aimed at measuring how well the study treatments work in their target patient groups.
Trial overview
The trial data includes two interventional studies that mention Aluminium Hydroxide or are part of the same trial set. One study is about early Alzheimer’s disease, and the other is about moderate to severe allergic rhinitis/rhinoconjunctivitis caused by house dust mite allergy.
Only the allergy study lists Aluminium Hydroxide as an intervention in the source data.
Early Alzheimer’s disease study
The Alzheimer’s disease trial was a Phase 2b, multicenter, randomized, placebo-controlled, double-blind study called ADVANCE.
It studied people with early Alzheimer’s disease and enrolled 58 participants.
The study was designed to assess whether AD04 could slow disease progression by looking at changes in thinking, daily function, and overall disease rating over 6 months.
This study was suspended, which means it was stopped before completion.
Allergy and rhinoconjunctivitis study
The allergy trial was a randomized, double-blind, placebo-controlled, multi-centre Phase 3 study in adults with moderate to severe allergic rhinitis/rhinoconjunctivitis with or without asthma caused by house dust mite allergy.
This study enrolled 582 participants and was completed.
Aluminium Hydroxide appears in the intervention list for this study, along with many other trial materials and treatments such as PURETHAL Mites, placebo, and medicines used for testing or symptom relief.
The brief summary says the main purpose was to assess the clinical efficacy of PM Mixture 50,000 AUeq/mL subcutaneous immunotherapy compared with placebo during one year of treatment.
Study design and phases
Both studies used an interventional design, which means the researchers gave a treatment or study product and then measured the results.
The Alzheimer’s trial used a randomized, placebo-controlled, double-blind design, which helps make the comparison fair and reduces bias.
The allergy trial also used randomization, placebo control, and double blinding, and it was done at multiple centers, meaning more than one study site took part.
In the trial data, Aluminium Hydroxide is linked to the allergy study rather than the Alzheimer’s study.
Main endpoints and what they mean
The Alzheimer’s study used a composite score, which combines several measures into one result.
Its primary outcome included cognition, daily function, and CDR-sb over 6 months, measured as overall time saved with treatment.
Cognition means thinking and memory, while daily function means how well a person can manage everyday activities.
The allergy study measured the average daily Total Combined Rhinitis Score during the last 8 weeks of treatment.
The summary explains that each symptom was graded and then added together to a maximum of 24 points, so the score gave one overall picture of nasal allergy symptoms.
Who participated
The Alzheimer’s study focused on patients with early Alzheimer’s disease and included 58 people.
The allergy study focused on adult subjects with moderate to severe allergic rhinitis/rhinoconjunctivitis with or without asthma due to house dust mite allergy and included 582 people.
These trials show that the research around Aluminium Hydroxide in the provided data is tied to specific patient groups and specific study goals, rather than general use in all patients.