Abstract Details

Title Reassessing Amyloid Modulation: Clinical Efficacy and Safety of Valiltramiprosate in Alzheimer's Disease

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P1 - Poster Session 1 (8:00 AM-9:00 AM)

Poster/Presentation
Number 12-007

Objective This study seeks to evaluate the efficacy and safety of Valiltramiprosate (ALZ-801) in Alzheimer's disease (AD) by emphasizing on cognitive and functional performance, brain volume changes, adverse effects and responses to the Apolipoprotein E4 (APOE e4) allele.

Background Alzheimer's disease is a progressive neurodegenerative disorder caused by abnormal protein deposition in the brain. Its prevalence in the world is 9.8 million, as of 2021. APOE e4 allele is a genetic determinant that precipitates accumulation of beta-amyloid protein, therefore predisposing an individual with two copies of the allele to early-onset AD. Valiltramiprosate (ALZ-801) is an oral drug that prevents neurotoxic beta-amyloid oligomer formation, potentially serving as a disease modifying treatment.

Design/Methods

This study reviews APOLLOE4 trial findings assessing the safety and efficacy of ALZ-801 in AD. AD Assessment Scale-Cognitive Subscale [ADAS-Cog13] and Clinical Dementia Rating-Sum of Boxes [CDR-SB] were used to measure cognitive improvement. Diffuse tensor imaging of hippocampus and Amyloid-related imaging abnormalities (ARIA) was conducted along with Disability Assessment for Dementia (DAD).

Results Treatment with ALZ-801 in the early AD population showed 18% hippocampal atrophy slowing but no significant improvement in cognitive performance. The mild cognitive impairment (MCI) subgroup, however, demonstrated enhanced cognitive functioning as shown by a 52% improvement on the ADAS- Cog13 test. Functional evaluation showed positive results of 96% and 102% on DAD and CDR-SB scores respectively, indicating improved functional abilities. MCI group exhibited 26% decrease in hippocampal atrophy. Commonly reported adverse effects included nausea, vomiting and loss of appetite, with no evidence of brain edema or hemorrhages.

Conclusions Studies for ALZ-801 in early AD population showed no notable clinical efficacy in the overall study population at 78 weeks. Nevertheless, the MCI subgroup reported significant reduction in brain atrophy progression and functional decline. No increase in ARIA or serious adverse events were evident, highlighting the safety and tolerability of the drug.

Authors/Disclosures
Purvi Kaurani, MBBS PRESENTER	Dr. Kaurani has nothing to disclose.
Shikha Gupta, MBBS	Dr. Gupta has nothing to disclose.
krishna V. Patidar, MBBS	Dr. Patidar has nothing to disclose.
Bhavana R. Metukuru, MBBS	Miss Metukuru has nothing to disclose.
Amit Joshi, MD	Dr. Joshi has nothing to disclose.
Tanishka M, MBBS	Miss M has nothing to disclose.
Parvin Mozafari, MD	Ms. Mozafari has nothing to disclose.
N/A Srijamya (ivane javakhishvili tbilisi state university)	Miss Srijamya has nothing to disclose.

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