CMAI

IGC Pharma Announces Positive Interim Results for IGC-AD1 in Reducing Alzheimer’s Agitation

Retrieved on: 
Wednesday, March 20, 2024
Biotechnology, Technology, Health, General Health, Pharmaceutical, Mental Health, Other Science, Other Technology, Research, Science, Clinical Trials, Agitation, AD1, Alzheimer's disease, Patient, CMAI, IGC, AAD, Caregiver burden, Dementia, Food, Pharmaceutical industry

IGC Pharma, Inc. (“IGC Pharma”, “IGC”, or the “Company”) (NYSE American: IGC) today announced the results of an interim analysis of its ongoing Phase 2 trial investigating IGC-AD1 as a treatment for Agitation in dementia from Alzheimer’s Disease (“AAD”).

Key Points: 
  • IGC Pharma, Inc. (“IGC Pharma”, “IGC”, or the “Company”) (NYSE American: IGC) today announced the results of an interim analysis of its ongoing Phase 2 trial investigating IGC-AD1 as a treatment for Agitation in dementia from Alzheimer’s Disease (“AAD”).
  • The interim data demonstrates a clinical and statistically significant reduction in agitation compared to placebo in patients with Alzheimer’s disease, indicating strong therapeutic potential for IGC-AD1.
  • "We are excited with the positive interim results from the Phase 2 trial of IGC-AD1 for agitation in dementia due to Alzheimer's disease.
  • IGC-AD1’s interim results demonstrate a clinical and statistically significant reduction in agitation compared to placebo, suggesting a strong plausibility to address a substantial unmet medical need.

Otsuka and Lundbeck Present New Data Analyses on the Efficacy of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease

Retrieved on: 
Monday, March 18, 2024
Research, FDA, Neurology, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Week, Psychosis, Agitation, Commercialization, Medication, Psychiatry, Caregiver, Patient, Geriatric psychiatry, Overalls, MD, Lundbeck, NPI, CMAI, Neuropsychiatry, Safety, Poster, Behavioral neuroscience, Multimedia, Dementia, Annual general meeting, Food

One poster utilized the Neuropsychiatric Inventory (NPI) to explore the relationship of REXULTI on neuropsychiatric symptoms relating to agitation and occupational disruptiveness/caregiver distress related to patients’ behavior.

Key Points: 
  • One poster utilized the Neuropsychiatric Inventory (NPI) to explore the relationship of REXULTI on neuropsychiatric symptoms relating to agitation and occupational disruptiveness/caregiver distress related to patients’ behavior.
  • The NPI, which is administered through a structured caregiver interview, is comprised of 12 domains of neuropsychiatric symptoms including agitation/aggression, irritability/lability, and disinhibition.
  • The analysis demonstrated that REXULTI was associated with reductions in overall neuropsychiatric symptoms and in agitation symptoms (as captured by the NPI) compared with placebo over 12 weeks.
  • “The breadth of data presented at AAGP represents our continued commitment to understanding the full potential of REXULTI on agitation associated with dementia due to Alzheimer’s disease.”

Otsuka Announces Phase 3 Topline Results of AVP-786 in the Treatment of Agitation Associated With Dementia Due to Alzheimer’s Disease

Retrieved on: 
Monday, February 12, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Incidence, Patient, Commercialization, Caregiver, OPDC, Medication, Death, CMAI, Otsuka Pharmaceutical, Dementia, Agitation, Pharmaceutical industry

Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC) and our parent company Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce topline results of the phase 3 clinical trial of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer’s disease (Trial 17-AVP-786-305; NCT03393520).

Key Points: 
  • Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC) and our parent company Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce topline results of the phase 3 clinical trial of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer’s disease (Trial 17-AVP-786-305; NCT03393520).
  • There were 4 deaths reported in the trial; 1 (0.5%) in the AVP-786 low dose group and 3 (1.4%) in the placebo group.
  • Further prespecified and exploratory analyses of the data set will be conducted to determine the full potential of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer’s disease.
  • “While the result of this trial is disappointing, we plan to analyze the full data set to determine the future potential of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer’s disease.

SciSparc Celebrates Major Breakthrough: Positive Results Show its Treatment has a Remarkable Impact on Alzheimer's Agitation

Retrieved on: 
Wednesday, November 15, 2023
Sophie, Hypotension, Cannabinoid, Alzheimer's disease, Eating, IMCA, Delirium, FDA, Agitation, Dronabinol, Tolerability, MD, CMAI, Central nervous system, Pharmaceutical industry, Medical device, Hospital, Disease, Patient, Safety

Tel-Aviv, Nov. 15, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (NASDAQ: SPRC), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (the “Company” or “SciSparc”), unveiled positive topline results from its investigator-initiated Phase IIa trial at the Sophie & Abraham Stuchynski Israeli Alzheimer’s Medical Center (IMCA). The trial results indicated that SciSparc’s proprietary SCI-110 provided a safe and effective solution for alleviating agitation in elderly Alzheimer's patients who participated.

Key Points: 
  • The trial results indicated that SciSparc’s proprietary SCI-110 provided a safe and effective solution for alleviating agitation in elderly Alzheimer's patients who participated.
  • Agitation is a devastating symptom of Alzheimer's Disease (AD), afflicting nearly all patients as the disease progresses, and imposing tremendous suffering and caregiving burdens.
  • The results not only met primary endpoints regarding tolerability and adverse events but also demonstrated SCI-110's potential to alleviate agitation without side effects.
  • Moreover, when measured by the Cohen Mansfield Agitation Inventory (CMAI), our treatment led to a significant 23% reduction in agitation symptoms.

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
Research, Mental Health, Neurology, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Behavioral neuroscience, Attention, Headache, Incidence, CMAI, Food, Mini–Mental State Examination, DSM-IV codes, Brexpiprazole, OPDC, MD, Psychiatry, Food and Drug Administration Amendments Act of 2007, Deficit spending, Verbal aggression, Dementia, Multimedia, Medicine, Interview, Pneumonia, Somnolence, Lundbeck, Locomotion, Commercialization, JAMA Neurology, Cachexia, Screaming, Caregiver, Passive-aggressive behavior, Aggression, Saint Louis University School of Medicine, MMSE, Heart, Ōtsuka, Akathisia, Contra body movement, Agitation, Medication, Tearing, Anxiety, IPA, Patient, Diagnosis, Disease, Restless, Pharmaceutical industry, Nursing, Birth control

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.

SciSparc Announces Successful Final Phase IIa Results, Meeting End Points of its Phase IIa Alzheimer Disease Patients with Agitation Trial

Retrieved on: 
Friday, June 2, 2023
Edinburgh, CMAI, Central nervous system, Delirium, Alzheimer's disease, Benzodiazepine, Hypotension, Disease, Tolerability, Eating, Quality of life, IMCA, Falls, Appetite, Doctor of Philosophy, Agitation, Dementia, MD, Mini–Mental State Examination, SD, AD, SCI, Edinburgh Feeding Evaluation in Dementia Scale, Sophie, Pharmaceutical industry, Medical imaging, Safety, Patient

Agitation manifests over the course of AD’s progression in almost all affected patients, increasing patients’ suffering and burden of care.

Key Points: 
  • Agitation manifests over the course of AD’s progression in almost all affected patients, increasing patients’ suffering and burden of care.
  • This Phase IIa clinical trial was an open label  trial, which included 18 patients diagnosed with AD and agitation, to evaluate the safety, tolerability, and efficacy trends of twice daily oral administration of SCI-110.
  • In general, the trial medication was well tolerated with no negative response to the treatment observed throughout the trial duration.
  • Alzheimer disease' patients experience many different symptoms that deteriorate their condition including lack of appetite, sleep quality and agitation.

FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer's Disease

Retrieved on: 
Thursday, May 11, 2023
Myenteric plexus, CMAI, Alzheimer's disease, Somnolence, Center for Drug Evaluation and Research, Deficit spending, Urinary tract infection, Boxed, Fast Track, Brain, Sleep, Agitation, Dementia, Insomnia, Dizziness, HIV disease progression rates, Patient, Division, Risk, Psychiatry, Diagnosis, Mini–Mental State Examination, Research, FDA, Headache, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Caregiver, Pharmaceutical industry, Residential care, Brexpiprazole, Common

"Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer's disease.

Key Points: 
  • "Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer's disease.
  • "These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression."
  • Agitation is among the most persistent, complex, stressful, and costly aspects of care among patients with behavioral and psychological symptoms of dementia.
  • The effectiveness of Rexulti for the treatment of agitation associated with dementia due to Alzheimer's disease was determined through two 12-week, randomized, double-blind, placebo-controlled, fixed-dose studies.

Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA) Approval of Supplemental New Drug Application (sNDA) for REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease

Retrieved on: 
Thursday, May 11, 2023
Mental Health, Research, FDA, Neurology, Genetics, Health, Pharmaceutical, General Health, Science, CMAI, Week, New Drug Application, Medication, Agitation, Incidence, Shanda, Dementia, Patient, Inabata & Co., Ltd., Otsuka Pharmaceutical, Diagnosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Brexpiprazole, Food, Caregiver, Safety, Residential care, Lundbeck

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Lundbeck LLC (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of REXULTI® (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease.

Key Points: 
  • Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Lundbeck LLC (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of REXULTI® (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease.
  • This approval makes REXULTI the first and only pharmacological treatment approved in the U.S. for agitation associated with dementia due to Alzheimer’s disease.
  • Agitation is a common neuropsychiatric symptom in Alzheimer’s dementia and one of the most complex and stressful aspects of caring for people living with the condition.
  • Brexpiprazole patients with agitation associated with dementia due to Alzheimer’s disease achieved a 31% greater reduction from baseline in frequency of agitation symptoms vs. placebo.

SciSparc Completed Treatment of Last Patient Enrolled for its Phase IIa Clinical Trial for Alzheimer's Disease and Agitation

Retrieved on: 
Tuesday, May 2, 2023
Edinburgh, CMAI, Central nervous system, Delirium, Alzheimer's disease, Pittsburgh Sleep Quality Index, Hypotension, Disease, Tolerability, Deficit spending, Falls, Appetite, Agitation, TEL, Dementia, MD, Mini–Mental State Examination, AD, Edinburgh Feeding Evaluation in Dementia Scale, Genta (company), Pharmaceutical industry, Medical imaging, Safety, Patient

TEL AVIV, Israel, May 02, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced that the last patient enrolled in the Company's Phase IIa trial of SCI-110 in patients with Alzheimer’s Disease (“AD”) and agitation, completed its treatment.

Key Points: 
  • TEL AVIV, Israel, May 02, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced that the last patient enrolled in the Company's Phase IIa trial of SCI-110 in patients with Alzheimer’s Disease (“AD”) and agitation, completed its treatment.
  • The Company is expecting to receive the final trial results in the upcoming weeks.
  • On November 7, 2022, the Company announced positive interim results from the open label trial, which includes 20 patients diagnosed with AD and agitation, to evaluate the safety, tolerability and efficacy trends of twice daily oral administration of SCI-110.
  • The interim results summarize the data from the first eight patients who completed the trial as per protocol.

Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Alzheimer’s Dementia

Retrieved on: 
Monday, April 17, 2023
Mental Health, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Commercialization, Lundbeck, CMAI, New Drug Application, Medication, Multimedia, Shanda, Joint meetings of the Australian Parliament, Patient, AAD, PDUFA, Peripheral, Caregiver, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, III, Agitation, Food, Pharmaceutical industry

The committee voted 9-1 that Otsuka and Lundbeck provided sufficient data to allow the identification of a population in whom the benefits of treating AAD with REXULTI outweigh its risks.

Key Points: 
  • The committee voted 9-1 that Otsuka and Lundbeck provided sufficient data to allow the identification of a population in whom the benefits of treating AAD with REXULTI outweigh its risks.
  • View the full release here: https://www.businesswire.com/news/home/20230416005072/en/
    If approved, REXULTI would be the first FDA-approved treatment indicated for AAD in the U.S.
  • “Agitation is one of the most complex and stressful aspects of care in patients affected by Alzheimer’s dementia,” said Johan Luthman, executive vice president, Lundbeck Research & Development.
  • Having an approved treatment option for AAD could provide hope to people impacted by this debilitating condition.”