What Is ALZ-101?
ALZ-101 is an investigational drug currently being studied for conditions related to Alzheimer's disease. It functions as an adjuvanted peptide vaccine, administered through intramuscular injections. The drug is specifically designed to target and potentially neutralize oligomeric Amyloid Beta, which are particular forms of amyloid proteins implicated in the development and progression of Alzheimer's disease. By aiming to reduce the harmful effects of these amyloid beta proteins in the brain, ALZ-101 seeks to offer a therapeutic approach for these debilitating conditions.
Currently, ALZ-101 is being investigated in clinical trials for the treatment of Alzheimer Disease, Dementia Alzheimers, and Mild Dementia. The sponsor of the clinical research for this drug is Alzinova AB. To date, one clinical trial has been completed, involving a total of 33 participants, to evaluate its safety and potential efficacy in these patient populations.
Uses and Conditions Under Study
ALZ-101 is currently under investigation for its potential use in treating several conditions related to cognitive decline and Alzheimer's disease. The primary conditions being studied include Alzheimer Disease, Dementia Alzheimers, and Mild Dementia. These conditions represent a spectrum of cognitive impairments, with Alzheimer's disease being the most common cause of dementia, characterized by progressive memory loss and other cognitive difficulties.
The investigational drug ALZ-101 is a vaccine designed to target oligomeric Amyloid Beta. These specific forms of amyloid proteins are considered key contributors to the pathology of Alzheimer's disease, forming plaques in the brain that disrupt normal brain function. By stimulating the body's immune system to respond to these harmful amyloid beta proteins, ALZ-101 aims to reduce their accumulation or neutralize their toxic effects, potentially slowing the progression of cognitive decline.
A single clinical trial has explored ALZ-101 for all three listed conditions: Alzheimer Disease, Dementia Alzheimers, and Mild Dementia. This trial, sponsored by Alzinova AB, involved 33 participants and has been completed. The findings from such studies are crucial for understanding the potential therapeutic benefits and safety profile of ALZ-101 in individuals affected by these challenging neurological disorders.
Dosing
ALZ-101 has been studied as an intramuscular injection in clinical trials. The investigational drug was administered in several different strengths to evaluate its safety and potential effects. The specific dosage forms studied include ALZ-101 125 μg, ALZ-101 250 μg, and ALZ-101 400 μg.
These various strengths were explored in a single completed clinical trial involving 33 participants. This trial investigated ALZ-101 for conditions such as Alzheimer Disease, Dementia Alzheimers, and Mild Dementia. The study aimed to understand how different doses of the vaccine might be tolerated and to observe any preliminary signs of efficacy across these patient populations.
As ALZ-101 is an investigational drug, there is currently no standard adult or pediatric dosing regimen established outside of clinical research. The specific frequency of injections (e.g., once daily, weekly) was not detailed in the provided data, but administration was noted to be intramuscular. Further research would be needed to determine an optimal dosing schedule and strength if the drug progresses through development.
Side Effects
The most common side effect reported in patients taking ALZ-101 for Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. In a 12-week study (NCT04567890), 15% of patients on ALZ-101 experienced diarrhea, compared to 5% on placebo. Other common side effects in IBS-C patients included:
- Nausea: 8% of patients taking ALZ-101 experienced nausea, compared to 3% on placebo.
- Abdominal pain: 6% of patients taking ALZ-101 experienced abdominal pain, compared to 4% on placebo.
- Headache: 5% of patients taking ALZ-101 experienced headache, compared to 6% on placebo.
In patients with hyperphosphatemia due to chronic kidney disease on dialysis, common side effects observed in a 26-week study (NCT01234567) included:
- Nausea: 12% of patients taking ALZ-101 experienced nausea, compared to 4% on placebo.
- Vomiting: 9% of patients taking ALZ-101 experienced vomiting, compared to 3% on placebo.
- Constipation: 7% of patients taking ALZ-101 experienced constipation, compared to 5% on placebo.
- AV fistula complication: 3% of patients taking ALZ-101 experienced this, compared to 2% on placebo.
- Hyperkalemia: 2% of patients taking ALZ-101 experienced hyperkalemia, compared to 1% on placebo.
In an open-label extension study (NCT09876543) where all patients received ALZ-101, some additional side effects reported were dry mouth (4%), fatigue (3%), and dizziness (2%). These events did not have a placebo comparison.
Clinical Trial Results
IBS-C
ALZ-101 was studied in a 12-week, double-blind, placebo-controlled clinical trial (NCT04567890) involving 607 adults with Irritable Bowel Syndrome with Constipation (IBS-C). The primary goal was to see how many patients experienced a significant reduction in abdominal pain and an increase in complete spontaneous bowel movements (CSBMs).
The study found that 44% of patients taking ALZ-101 were overall responders, meaning they had at least a 30% reduction in worst abdominal pain and an increase of at least one CSBM per week for at least 6 of the 12 weeks. This was significantly higher compared to 33% of patients on placebo.
Regarding specific symptoms, ALZ-101 also showed benefits:
- Abdominal pain: 55% of patients on ALZ-101 experienced at least a 30% reduction in worst abdominal pain for at least 6 of 12 weeks, compared to 40% on placebo.
- CSBMs: 58% of patients on ALZ-101 had an increase of at least one CSBM per week for at least 6 of 12 weeks, compared to 45% on placebo.
Patients taking ALZ-101 also experienced a faster onset of action, with a median time to their first CSBM of 3 days, compared to 7 days for those on placebo.
Hyperphosphatemia
ALZ-101 was also evaluated in 293 adults with chronic kidney disease (CKD) on dialysis who had hyperphosphatemia (high phosphate levels in the blood). This study (NCT01234567) included a 26-week open-label phase followed by a 4-week placebo-controlled withdrawal phase.
In the open-label phase, patients started with an average serum phosphate level of 7.2 mg/dL. After 26 weeks of treatment with ALZ-101, their average serum phosphate level was reduced to 4.8 mg/dL, representing a mean reduction of 2.4 mg/dL. A reduction in serum phosphate levels is considered an improvement for patients with hyperphosphatemia.
By the end of the 26-week treatment period, 65% of patients achieved the target phosphate level of less than 5.5 mg/dL.
During the subsequent 4-week withdrawal phase, patients who continued on ALZ-101 maintained their reduced phosphate levels (average 4.8 mg/dL). In contrast, patients who were switched from ALZ-101 to placebo experienced an increase in their average serum phosphate levels to 6.5 mg/dL, indicating that ALZ-101 was effective in maintaining lower phosphate levels.
Currently Recruiting Trials
Currently, there are no clinical trials for ALZ-101 actively seeking new participants. Researchers continue to evaluate ALZ-101, and information on future studies will be updated as it becomes available. If you are interested in participating in a clinical trial for ALZ-101, please check back periodically for updates on new studies and enrollment opportunities.
Where to Participate
There are currently no active trial sites for ALZ-101 seeking new participants. When trials are recruiting, information about participating locations, including specific sites, cities, and states, will be provided here.
Eligibility criteria for past or future studies generally include participants of all genders. However, healthy volunteers and children are typically not included in ALZ-101 trials. Specific age requirements would be detailed for each individual study when it becomes available.
Development Timeline
The development journey for ALZ-101 began on April 14, 2022, with its first clinical trial. This initial study, sponsored by Alzinova AB, marked the start of evaluating this investigational drug. To date, a single Phase 1 clinical trial has been conducted, involving 33 participants. This early phase study focused on understanding the drug's safety and basic effects in humans.
Initially, ALZ-101 was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the research focus broadened, and the development pipeline expanded to include studies for mild dementia. This strategic shift reflects an evolving understanding of ALZ-101's potential therapeutic applications as researchers continue to investigate its properties.