APOLLOE4 Study: Are you or someone you know struggling with memory loss?

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NF52
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Re: APOLLOE4 Study: Are you or someone you know struggling with memory loss?

Post by NF52 »

The August Alzheimer's Association International Conference (AAIC) had a presentation by Alzheon, Inc, referencing benefit to people with ApoE 4 and early stage (mild) AD from the Phase 2 trial of ALZ-801, a pro-drug of tramiprosate. Today a company news release provides specific information on safety, percentage reduction of p-tau 181 in the blood, and cognitive scores after 12 months in the Phase 2 study of 84 people with either ApoE 3/4 or 4/4 in Europe. This is also the first drug, to my knowledge, to dramatically reduce blood (plasma) levels of phosphorylated tau (P-tau) and result in stable cognitive scores and hippocampal volume in people with mild AD in the 12 month period.

A link to the release is HERE. Excerpts below are from the release; bolded statement are my emphasis.

Explanation of the current Phase 3 APOLLOE4 trial enrolling 300 people with MCI/mild AD for 18 months of ALZ-801 is also below. [Full disclosure: I have no financial interest in this company and am not in their clinical trial. I do have an ApoE 4/4 interest in this drug!]
Alzheon, Inc.,...today reported statistically significant and clinically relevant plasma biomarker reduction, robust preservation of brain volume, and positive memory effects in Alzheimer’s patients following 12 months of treatment with investigational agent ALZ-801 in its Phase 2 biomarker trial.
...
Phosphorylated tau (p-tau) levels in plasma are a sensitive and specific marker of neuronal stress and brain injury in AD, and considered a highly reliable biomarker of disease pathology. P-tau is produced by neurons as a reaction to formation of toxic beta amyloid oligomers, the key driver of AD pathology and neurodegeneration. P-tau181 levels rise with AD progression and clinical deterioration of patients, and have been shown to fall in response to clinically effective disease modifying treatments in Alzheimer’s. ...

"combined with preservation of brain hippocampal volume and a favorable safety profile with no events of vasogenic edema, these new biomarker data and their positive correlations with cognitive benefits further validate the disease modifying effects of ALZ-801 in Alzheimer’s patients,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon. “Importantly, rather than slowing the cognitive decline of patients as seen in trials with other agents, subjects treated with ALZ-801 demonstrated cognitive gain from baseline status on memory tests and maintained their cognitive skills over 1 year.
...
The APOLLOE4 Phase 3 study [An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early Alzheimer's Disease Subjects (NCT04770220)] with ALZ-801,...is enrolling the highest-risk homozygous APOE4/4 AD patients and incorporates the latest volumetric MRI measures and biomarkers to track patient benefit – levels of p-tau181 and beta amyloid in plasma and cerebrospinal fluid, hippocampal volume, and other volumetric brain measures, along with the gold-standard primary clinical endpoint, ADAS-Cog 13 (Alzheimer's Disease Assessment Scale-Cognitive Subscale). ... This ongoing study is designed to evaluate the efficacy, safety, biomarker and imaging effects of 265 mg twice daily oral dose of ALZ-801 in Early AD subjects with the APOE4/4 genotype, who constitute approximately 15% of Alzheimer's patients. This is a double-blind, randomized trial comparing oral ALZ-801 to placebo treatment over 78 weeks. The APOLLOE4 trial is supported by a $47 million grant from the National Institute on Aging.
...
About ALZ-801
ALZ-801 (valiltramiprosatet) is an investigational oral agent in Phase 3 development as a potentially disease modifying treatment for AD.1,3 In mechanism of action studies, ALZ-801 has been shown to fully inhibit the formation of neurotoxic soluble beta amyloid oligomers at the Phase 3 clinical dose.5,6 ALZ‑801 acts through a novel enveloping molecular mechanism of action to fully block formation of neurotoxic soluble amyloid oligomers in the human brain7 associated with the onset of cognitive symptoms and progression of AD.1–4 ALZ-801 received Fast Track designation from the U.S. Food and Drug Administration in 2017. The clinical data for ALZ-801 and Alzheon’s safety database indicate a favorable safety profile.5–7,9 The initial Phase 3 program for ALZ-801 is focusing on Early AD patients with the APOE4/4 genotype, with future expansion to AD treatment and prevention in patients carrying one copy of the APOE4 gene and noncarriers.1–4
4/4 and still an optimist!
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