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AriBio Co., Ltd. Announces Global Expansion of POLARIS-AD, A Phase 3 Early Alzheimer’s Disease Registration Trial

Retrieved on: 
Tuesday, November 14, 2023
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AriBio Co., Ltd. (AriBio) announces the global expansion of the POLARIS-AD study, a phase 3 early Alzheimer’s disease trial into the European Union, United Kingdom, Korea and China.

Key Points: 
  • AriBio Co., Ltd. (AriBio) announces the global expansion of the POLARIS-AD study, a phase 3 early Alzheimer’s disease trial into the European Union, United Kingdom, Korea and China.
  • The phase 3 study is a double-blind, randomized, placebo-controlled, multi-center registration trial to evaluate the efficacy and safety of AR1001 (mirodenafil dihydrochloride) over 52 weeks of treatment in patients with early Alzheimer’s disease.
  • This global trial by AriBio highlights the regulatory appetite for further research for Alzheimer’s disease and the need for alternative safe and oral therapies compared to the recently FDA approved monoclonal antibodies.
  • AriBio is well positioned and adequately financed to execute on this global expansion”, stated Matthew Choung, Chairman and Chief Executive Officer (CEO) of AriBio.

Cognition Therapeutics Completes Enrollment in Phase 2 SHINE Study of CT1812 in Mild-to-Moderate Alzheimer’s Disease

Retrieved on: 
Tuesday, November 7, 2023
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PURCHASE, N.Y., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), (the “Company” or “Cognition”), today announced that the last participant was randomized in the Phase 2 SHINE study (NCT03507790) of CT1812, the company’s lead candidate for the treatment of age-related neurodegenerative diseases of the CNS and retina. A total of 153 adults with mild-to-moderate (MMSE 18-26) Alzheimer's disease were randomized to receive either placebo or oral doses of CT1812 (100 mg or 300 mg). Endpoints include safety, change in cognitive function, as measured by ADAS-Cog 11 and biomarker evidence of disease modification. Top-line results are expected in mid 2024 after the last participants have completed six months of treatment.

Key Points: 
  • A total of 153 adults with mild-to-moderate (MMSE 18-26) Alzheimer's disease were randomized to receive either placebo or oral doses of CT1812 (100 mg or 300 mg).
  • Endpoints include safety, change in cognitive function, as measured by ADAS-Cog 11 and biomarker evidence of disease modification.
  • “Results of the SHINE trial will provide important information on safety, tolerability and cognitive effects of CT1812 in people with mild-to-moderate Alzheimer’s disease, and these results will inform our plans for Phase 3 development,” Lisa Ricciardi , president and CEO of Cognition Therapeutics stated.
  • “Completing enrollment in the trial ahead of our 2023 target allows us to bring proof-of-concept results sooner and provides savings to our company.

JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease

Retrieved on: 
Monday, November 6, 2023
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REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.

Key Points: 
  • REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.
  • Participants also required a diagnosis that met The International Psychogeriatric Association’s (IPA) provisional definition of agitation in patients with cognitive impairment or dementia.
  • “Agitation associated with dementia due to Alzheimer’s disease can be very challenging and emotionally distressing for patients and family members caring for them.
  • The trial had high rates of patients completing the trial: 86.8% of the brexpiprazole group and 88.9% of the placebo group.

NKGen Biotech Presented Phase I Clinical Trial Data at the 16th Annual Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Retrieved on: 
Thursday, October 26, 2023
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SANTA ANA, Calif., Oct. 26, 2023 (GLOBE NEWSWIRE) -- NKGen Biotech Inc. (Nasdaq: NKGN) (NKGen or the Company), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer cell therapeutics, today presented a poster with Phase I trial data on the use of its investigational NK cell therapy, SNK01, to treat patients with Alzheimer’s disease (AD) at the Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting in Boston, MA.

Key Points: 
  • The severity of AD was based on the baseline Clinical Dementia Rating-Sum of Boxes, or CDR-SB score.
  • The primary endpoint was safety and secondary endpoints included changes in cognitive assessments and biomarker levels.
  • We are very excited to begin this next phase in hopes of establishing an entirely new treatment paradigm for more advanced patients."
  • *Data at Week 22 was only obtained for nine of the ten patients.

Blinded Data Presented at CTAD Suggest that NE3107 is Biologically Active and May Have Impact on Cognitive, Biomarker, and Imaging Endpoints Among Mild to Moderate Alzheimer’s Disease Patients

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Wednesday, October 25, 2023
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A significant change from baseline was observed in the Amyloid β 42/40 ratio and Amyloid Probability Score as shown by the PrecivityAD® tests from C2N Diagnostics.

Key Points: 
  • A significant change from baseline was observed in the Amyloid β 42/40 ratio and Amyloid Probability Score as shown by the PrecivityAD® tests from C2N Diagnostics.
  • Increased FDG-PET SUVRs were observed in 10 out of 21 patients in a brain imaging sub-study, which is suggestive of reduced amyloid burden.
  • The Company expects to announce unblinded, topline data from this trial in late November or early December.
  • The blinded data presented suggest that NE3107 is a biologically active compound exerting potential effects as observed by biomarker, imaging, cognitive and functional assessments.

New Data from Biogen’s Investigational Antisense Oligonucleotide (ASO) Targeting Tau Shows Promise for Potential New Generation of Treatments in Early Alzheimer’s Disease

Retrieved on: 
Wednesday, October 25, 2023
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First study of a tau targeting drug that shows reduction of aggregated tau pathology and favorable trends on clinical outcomes.

Key Points: 
  • First study of a tau targeting drug that shows reduction of aggregated tau pathology and favorable trends on clinical outcomes.
  • CAMBRIDGE, Mass., Oct. 25, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) reported new Phase 1b clinical data from the study of BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, in mild Alzheimer’s disease (AD).
  • The late-breaking results were presented at the 2023 Clinical Trials on Alzheimer’s Disease (CTAD) meeting held in Boston, MA from October 24-27.
  • The favorable trends suggest a potential link between a reduction in tau PET pathology and clinical outcomes.

Araclon Biotech Presents Positive Final Results from Phase 2 Clinical Study of ABvac40 Alzheimer’s Vaccine at CTAD

Retrieved on: 
Tuesday, October 24, 2023
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Araclon gave a late-breaking presentation at the 2023 Clinical Trials on Alzheimer's Disease (CTAD) conference.

Key Points: 
  • Araclon gave a late-breaking presentation at the 2023 Clinical Trials on Alzheimer's Disease (CTAD) conference.
  • Data confirm preliminary findings indicating a comparable safety profile between ABvac40 and placebo groups, with similar rates of treatment-emergent adverse events.
  • In addition, volumetric magnetic resonance imaging showed a lesser increase in whole brain atrophy in the ABvac40 group vs placebo.
  • The results reported for ABvac40 to date validate its clinical potential, positioning it as promising therapeutic candidate for early AD treatment.

Altoida's AR-based Digital Cognitive and Functional Assessment Correlates with Standard Neuropsychological Tests in MCI and Healthy Volunteers

Retrieved on: 
Tuesday, October 24, 2023
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Digital cognitive assessments offer the potential to facilitate frequent and unbiased measurements of cognitive functional status, without the need of a trained rater,” said Marc Jones, CEO, Altoida.

Key Points: 
  • Digital cognitive assessments offer the potential to facilitate frequent and unbiased measurements of cognitive functional status, without the need of a trained rater,” said Marc Jones, CEO, Altoida.
  • Participants received a neurological evaluation, a neuropsychological test battery, and Altoida’s digital cognitive assessment.
  • The study evaluated the correlation between Altoida’s digital cognitive assessment and standard neuropsychological tests, including: the Mini-Mental State Examination (MMSE) - the Free and Cued Selective Reminding Test (FCSRT) - the Trail Making Test (TMT).
  • Altoida's digital cognitive assessment provides a Digital Neuro-Signature™ (DNS-MCI) score correlated with classical neuropsychological tests that are commonly used as a battery when evaluating patients in clinical research and clinical practice.

NKGen Biotech Presents Interim Phase I Trial Data at the XXVI World Congress of Neurology (WCN) Annual Meeting 2023

Retrieved on: 
Tuesday, October 17, 2023
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Severity of AD was based on the baseline Clinical Dementia Rating-Sum of Boxes, or CDR-SB score.

Key Points: 
  • Severity of AD was based on the baseline Clinical Dementia Rating-Sum of Boxes, or CDR-SB score.
  • “The results from our Alzheimer’s trial demonstrate that SNK01 has the potential to cross the blood-brain barrier as evidenced by the CSF biomarker data,” said Paul Y.
  • The pressing need for effective Alzheimer’s treatments cannot be overstated, and we are committed to addressing this healthcare challenge.
  • Based on the CSF biomarker data, intravenous SNK01 appears to cross the blood brain barrier to improve CSF AB42/40 and reduce pTau181 levels.

IntellxxDNA’s Innovative Memory and Genomics Decision-Making Tool Study Gains IRB Approval

Retrieved on: 
Monday, October 16, 2023
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Signifying a new era in cognitive health research, IntellxxDNA™ is proud to announce its IRB approval for the GPS-MEM Study: A Precision Study of Memory.

Key Points: 
  • Signifying a new era in cognitive health research, IntellxxDNA™ is proud to announce its IRB approval for the GPS-MEM Study: A Precision Study of Memory.
  • The study will evaluate the efficacy of IntellxxDNA's clinical decision support (CDS) tool.
  • The final goal is to gather feedback from medical practitioners on how significantly the IntellxxDNA™ genomics tool influenced and aided their decision-making process.
  • The study obtained IRB approval on August 16, 2023, with Protocol Number INT-MEM-101 and Approval Number: IRCM-2023-376.