Cognition Therapeutics Presents Poster of Participant Demographics from Phase 2 Dementia with Lewy Bodies Study at CTAD
Cognition Therapeutics (NASDAQ: CGTX) presented baseline characteristics of participants in their Phase 2 'SHIMMER' study for dementia with Lewy bodies (DLB) at the CTAD conference. The study includes 130 participants with these key characteristics: mean age of 72.8 years, 81.5% male, 91.5% white, with mild-to-moderate cognitive impairment. Participants showed mean scores of 24.0 for MMSE, 18.4 for MoCA, and various other clinical measurements indicating mild movement impairment and attention fluctuations consistent with DLB diagnosis. The company expects to announce study results later this year.
Cognition Therapeutics (NASDAQ: CGTX) ha presentato le caratteristiche di base dei partecipanti al loro studio di Fase 2 'SHIMMER' per demenza con corpi di Lewy (DLB) durante la conferenza CTAD. Lo studio comprende 130 partecipanti con queste caratteristiche chiave: età media di 72,8 anni, 81,5% maschi, 91,5% bianchi, con lieve-moderata compromissione cognitiva. I partecipanti hanno mostrato punteggi medi di 24,0 per l'MMSE, 18,4 per il MoCA e varie altre misurazioni cliniche che indicano lievi problemi motori e fluttuazioni dell'attenzione coerenti con la diagnosi di DLB. L'azienda prevede di annunciare i risultati dello studio entro la fine dell'anno.
Cognition Therapeutics (NASDAQ: CGTX) presentó las características iniciales de los participantes en su estudio de Fase 2 'SHIMMER' para demenicia con cuerpos de Lewy (DLB) en la conferencia CTAD. El estudio incluye 130 participantes con estas características clave: edad media de 72.8 años, 81.5% hombres, 91.5% blancos, con deterioro cognitivo leve a moderado. Los participantes mostraron puntuaciones medias de 24.0 en el MMSE, 18.4 en el MoCA y varias otras mediciones clínicas que indican leve deterioro del movimiento y fluctuaciones de atención consistentes con el diagnóstico de DLB. La empresa espera anunciar los resultados del estudio más adelante este año.
Cognition Therapeutics (NASDAQ: CGTX)는 CTAD 컨퍼런스에서 루이체 치매 (DLB)에 대한 2상 'SHIMMER' 연구 참가자들의 기초 특성을 발표했습니다. 이 연구는 130명의 참가자를 포함하며, 이들의 주요 특성은 다음과 같습니다: 평균 연령 72.8세, 남성 81.5%, 백인 91.5%, 경미한-중간 인지 장애가 있는 경우입니다. 참가자들은 MMSE에서 평균 24.0, MoCA에서 18.4의 점수를 보였고, DLB 진단과 일치하는 약간의 운동 장애와 주의력 변동을 나타내는 다양한 임상 측정을 기록했습니다. 회사는 올해 말 연구 결과를 발표할 예정입니다.
Cognition Therapeutics (NASDAQ: CGTX) a présenté les caractéristiques de base des participants à leur étude de Phase 2 'SHIMMER' pour la démence à corps de Lewy (DLB) lors de la conférence CTAD. L'étude comprend 130 participants présentant ces caractéristiques clés : âge moyen de 72,8 ans, 81,5 % d'hommes, 91,5 % de blancs, avec des troubles cognitifs légers à modérés. Les participants ont enregistré des scores moyens de 24,0 pour le MMSE, 18,4 pour le MoCA, ainsi que diverses autres mesures cliniques indiquant des troubles moteurs légers et des fluctuations d'attention cohérentes avec le diagnostic de DLB. La société prévoit d'annoncer les résultats de l'étude plus tard cette année.
Cognition Therapeutics (NASDAQ: CGTX) präsentierte die Basiseigenschaften der Teilnehmer an ihrer Phase-2-Studie 'SHIMMER' für Demenzi mit Lewy-Körpern (DLB) auf der CTAD-Konferenz. Die Studie umfasst 130 Teilnehmer mit diesen Schlüsseldaten: Durchschnittsalter von 72,8 Jahren, 81,5% Männer, 91,5% Weiße, mit leicht bis moderat ausgeprägten kognitiven Beeinträchtigungen. Die Teilnehmer erzielten durchschnittliche Werte von 24,0 im MMSE, 18,4 im MoCA und verschiedene andere klinische Messungen, die auf leichte Bewegungsstörungen und Aufmerksamkeitschwankungen hinweisen, die mit der DLB-Diagnose übereinstimmen. Das Unternehmen plant, die Studienergebnisse später in diesem Jahr bekannt zu geben.
- Phase 2 trial successfully enrolled 130 participants
- Patient characteristics align with other DLB studies, validating trial design
- Study results expected later this year, indicating trial progress on schedule
- None.
Insights
The presentation of baseline demographics from the Phase 2 SHIMMER study, while providing insight into trial participant characteristics, does not represent significant market-moving news. The data shows expected participant profiles with mean age of 72.8 years and cognitive scores typical for mild-to-moderate DLB patients, but lacks efficacy or safety results. The upcoming readout later this year will be more impactful for evaluating CT1812's potential in treating DLB, a significant market with 1.4 million affected Americans.
The participant characteristics align with standard DLB trial demographics, suggesting proper patient selection but offering no indication of treatment success. For a micro-cap company (
- Patient characteristics are consistent with other DLB studies -
PURCHASE, N.Y., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, presented participant baseline characteristics in the Phase 2 ‘SHIMMER’ study of mild-to-moderate dementia with Lewy bodies (DLB). The poster is being presented at the 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference being held October 29 – November 1, 2024 in Madrid, Spain and is available on Cognition’s website.
“Looking at the mean scores, participants who entered our DLB study had mild-to-moderate levels of cognitive impairment; the severity of their fluctuations in attention were consistent with a clinical diagnosis of DLB; and most participants had mild movement impairment,” explained Anthony Caggiano, M.D., Ph.D., Cognition’s CMO and head of R&D.
Baseline characteristics of the 130 participants enrolled in the study, as described in the poster:
| Mean Age | 72.8 years |
| Sex | |
| Race | |
| Mean mini-mental state examination (MMSE) score | 24.0 |
| Mean Montreal Cognitive Assessment (MoCA) score | 18.4 |
| Mean Clinician Assessment of Fluctuation (CAF) score | 5.9 |
| Mean Epworth Sleepiness Scale (ESS) score | 8.4 |
| Mean MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score | 27.7 |
| Mean Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score | 62.5 |
“DLB is one of the most common forms of dementia and a complex neurological condition. Symptoms include cognitive, motor, psychological and behavioral impairment that change over time as the disease progresses,” stated Lisa Ricciardi, Cognition’s president and CEO. “These characteristics are similar to participant demographics from other signal-finding studies in DLB. We look forward to reading out the results of our study later this year.”
CTAD Poster Details:
| Title: | SHIMMER: Baseline Data and Early Lessons from the Ongoing Phase 2 Signal-finding Study of CT1812 in Mild-to-Moderate Dementia with Lewy Bodies (DLB) | |
| Authors: | Galvin JE, Tolea MI, Iaci JF, Devins T, Hamby ME, Grundman M, Caggiano AO | |
| Session: | Clinical Trials – Methodology: October 29-30, 2024 |
About Dementia with Lewy Bodies (DLB)
Dementia with Lewy bodies is the second most common form of dementia, affecting an estimated 1.4 million Americans. The disease is believed to be caused by a buildup of the protein α-synuclein, which aggregates in Lewy bodies, which are found within brain neurons. DLB is referred to as a “whole-body” disease, as it disrupts biological processes affecting autonomic, digestive, cognitive, and motor systems. Varied initial symptoms may include day-to-day fluctuations in alertness level, hallucinations, delusions, movement disorders and REM sleep disorder (acting out dreams while sleeping). Only a few symptomatic treatments for DLB are approved and currently there are no disease-modifying therapeutics.
About the SHIMMER Study
The SHIMMER study is a double-blind, placebo-controlled Phase 2 clinical trial that enrolled 130 adults with mild-to-moderate DLB. Participants were evenly randomized to receive either placebo or one of two oral once-daily doses of CT1812 (100 mg or 300 mg) for six months. Participants are assessed throughout the study using the Montreal Cognitive Assessment (MoCA) and Mini Mental State Examination (MMSE), which track cognitive performance; the Clinician Assessment of Fluctuation (CAF) to measure the frequency and duration of cognitive fluctuations; and the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, an objective assessment of parkinsonism.
The SHIMMER study is supported by a grant award from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately
About CT1812
CT1812 is an experimental orally delivered small molecule oligomer antagonist that penetrates the blood-brain barrier and binds selectively to the sigma-2 (σ-2) receptor complex. Preclinical and clinical data demonstrate that this binding results in the displacement of toxic Aβ oligomers. The σ-2 receptor complex is involved in the regulation of key cellular processes such as membrane trafficking and autophagy that are damaged by toxic interaction with Aβ oligomers, oxidative stress and other stressors. This damage to sensitive synapses can progress to a loss of synaptic function, which manifests as cognitive impairment and Alzheimer’s disease progression.
Participants are currently being recruited in the START study (NCT05531656) of CT1812 in adults with early Alzheimer’s disease; and the MAGNIFY study (NCT05893537) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration. Enrollment has completed in the SHIMMER study (NCT05225415) of CT1812 in adults with dementia with Lewy bodies.
About Cognition Therapeutics, Inc.
Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We are currently investigating our lead candidate CT1812 in clinical programs in Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases. We believe that targeting the σ-2 receptor with CT1812 represents a mechanism functionally distinct from other current approaches in clinical development for the treatment of degenerative diseases. More about Cognition Therapeutics and its pipeline can be found at https://cogrx.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including CT1812, and any expected or implied benefits or results, including that initial clinical results observed with respect to CT1812 will be replicated in later trials and our clinical development plans, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impact of the COVID-19 pandemic on our business, supply chain and labor force; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
| Contact Information: Cognition Therapeutics, Inc. info@cogrx.com | Casey McDonald (media) Tiberend Strategic Advisors, Inc. cmcdonald@tiberend.com | Mike Moyer (investors) LifeSci Advisors mmoyer@lifesciadvisors.com |
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FAQ
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