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1 Trial |
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1 Trial |  |
3 News |  |
- | IONIS-MAPTRx / Biogen
Biomarker, Review, Journal: Developing Topics. (Pubmed Central) - Jan 12, 2025
These findings suggest its potential as a therapeutic intervention to target tau pathology and alter the course of AD. Further research is warranted to establish its clinical effectiveness and long-term safety profile.
- | Journal: Drug Development. (Pubmed Central) - Jan 12, 2025
and tau pathologies in AD. The model can be utilized to explore dosing regimens to support the development of combination therapy.
- | IONIS-MAPTRx / Biogen
Trial completion date, Trial primary completion date: A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled BIIB080 Co-administered With BIIB080 in Healthy Adults (clinicaltrials.gov) - Jan 10, 2025
P1, N=5, Not yet recruiting, Sponsor: Biogen
The model can be utilized to explore dosing regimens to support the development of combination therapy. Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Feb 2025 --> Feb 2026
- | IONIS-MAPTRx / Biogen
Trial initiation date: A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled BIIB080 Co-administered With BIIB080 in Healthy Adults (clinicaltrials.gov) - Nov 6, 2024
P1, N=5, Not yet recruiting, Sponsor: Biogen
Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Feb 2025 --> Feb 2026 Initiation date: Oct 2024 --> Jan 2025
- ||| IONIS-MAPTRx / Biogen
Enrollment closed: CELIA: A Study to Learn About the Safety of BIIB080 Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age (clinicaltrials.gov) - Aug 14, 2024
P2, N=364, Active, not recruiting, Sponsor: Biogen
Initiation date: Oct 2024 --> Jan 2025 Recruiting --> Active, not recruiting
- ||| IONIS-MAPTRx / Biogen
Enrollment change, Trial completion date, Trial primary completion date: CELIA: A Study to Learn About the Safety of BIIB080 Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age (clinicaltrials.gov) - Aug 5, 2024
P2, N=364, Recruiting, Sponsor: Biogen
Recruiting --> Active, not recruiting N=735 --> 364 | Trial completion date: Feb 2030 --> Jan 2029 | Trial primary completion date: Nov 2027 --> May 2026
- | IONIS-MAPTRx / Biogen
Trial primary completion date: A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled BIIB080 Co-administered With BIIB080 in Healthy Adults (clinicaltrials.gov) - Jul 19, 2024
P1, N=5, Not yet recruiting, Sponsor: Biogen
N=735 --> 364 | Trial completion date: Feb 2030 --> Jan 2029 | Trial primary completion date: Nov 2027 --> May 2026 Trial primary completion date: Jul 2025 --> Feb 2025
- Quantitative Systems Pharmacology Model for Therapies Targeting A? and Tau Pathologies in Alzheimer (Exhibit (Pennsylvania Convention Center); In-Person) - Jun 19, 2024 - Abstract #AAIC2024AAIC_3655;
and tau pathologies in AD. The model can be utilized to explore dosing regimens to support the development of combination therapy.
- IONIS-MAPTRx / Biogen
Exploratory clinical outcomes from BIIB080 (MAPT ASO) phase 1b multiple ascending dose and long-term extension study in mild Alzheimer (201 ABC (Pennsylvania Convention Center)) - Jun 19, 2024 - Abstract #AAIC2024AAIC_2431;
Caution should be taken in interpretation given small sample size and use of external controls in the LTE. These data support investigation of BIIB080 in the CELIA phase 2 trial.
- || IONIS-MAPTRx / Biogen
New P1 trial: A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled BIIB080 Co-administered With BIIB080 in Healthy Adults (clinicaltrials.gov) - Jun 11, 2024
P1, N=5, Not yet recruiting, Sponsor: Biogen
- || IONIS-MAPTRx / Biogen
Trial completion date, Trial primary completion date: CELIA: A Study to Learn About the Safety of BIIB080 Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age (clinicaltrials.gov) - Dec 20, 2023
P2, N=735, Recruiting, Sponsor: Biogen
These data support investigation of BIIB080 in the CELIA phase 2 trial. Trial completion date: Dec 2026 --> Feb 2030 | Trial primary completion date: Dec 2026 --> Nov 2027
- || IONIS-MAPTRx / Ionis
Biomarker, Clinical, Journal: Exploratory Tau Biomarker Results From a Multiple Ascending-Dose Study of BIIB080 in Alzheimer Disease: A Randomized Clinical Trial. (Pubmed Central) - Dec 17, 2023
P1/2
Effects of BIIB080 on biomarkers and clinical outcomes are being further evaluated in a phase 2 trial. ClinicalTrials.gov Identifier: NCT03186989.
- IONIS-MAPTRx / Ionis
Design of a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of BIIB080 in Subjects with Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease Dementia (In-Person) - Jul 6, 2023 - Abstract #AAIC2023AAIC_1686;
P1/2, P2
ClinicalTrials.gov Identifier: NCT03186989. The ongoing Ph2 CELIA trial will assess the efficacy, safety and tolerability of BIIB080, compared to placebo in subjects with MCI due to Alzheimer
- | IONIS-MAPTRx / Ionis
Journal: The development of peptide- and oligonucleotide-based drugs to prevent the formation of abnormal tau in tauopathies. (Pubmed Central) - May 1, 2023
A Phase II trial of BIIB080 is ongoing in mild AD. Neurotrophic and neurogenic peptide mimetic compounds have also shown potential as treatment options for AD and other tauopathies.
- IONIS-MAPTRx / Ionis
EXPLORATORY BIOMARKER RESULTS FROM A MULTIPLE ASCENDING DOSE SAFETY AND TOLERABILITY STUDY OF BIIB080 (MAPT ASO) IN ALZHEIMER'S DISEASE (On-Demand Oral Gallery F) - Dec 23, 2022 - Abstract #ADPD2023ADPD_1133;
P1/2, P2
A moderate relationship was observed between the model-predicted cumulative CSF drug exposure (area under the curve) and tau PET change in each region. Conclusions BIIB080 reduces biomarkers associated with tau pathophysiology including CSF tau and tau PET in patients with mild Alzheimer's disease.
- | IONIS-MAPTRx / Ionis
Trial primary completion date: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - Oct 5, 2022
P1/2, N=46, Completed, Sponsor: Ionis Pharmaceuticals, Inc.
Conclusions BIIB080 reduces biomarkers associated with tau pathophysiology including CSF tau and tau PET in patients with mild Alzheimer's disease. Trial primary completion date: Sep 2020 --> May 2022
- || IONIS-MAPTRx / Ionis
Trial completion: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - Aug 4, 2022
P1/2, N=46, Completed, Sponsor: Ionis Pharmaceuticals, Inc.
Trial primary completion date: Sep 2020 --> May 2022 Active, not recruiting --> Completed
- |||| IONIS-MAPTRx / Biogen
Enrollment open: CELIA: A Study to Learn About the Safety of BIIB080 Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age (clinicaltrials.gov) - Jul 29, 2022
P2, N=735, Recruiting, Sponsor: Biogen
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- ||||| IONIS-MAPTRx / Biogen
New P2 trial: CELIA: A Study to Learn About the Safety of BIIB080 Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age (clinicaltrials.gov) - May 31, 2022
P2, N=735, Not yet recruiting, Sponsor: Biogen
- IONIS-MAPTRx / Ionis
[VIRTUAL] Results of the First-in-Human, Randomized, Double-Blind, Placebo-Controlled Phase 1b Study of Lumbar Intrathecal Bolus Administrations of Antisense Oligonucleotide (ISIS 814907; BIIB080) Targeting Tau mRNA in Patients with Mild Alzheimer’s Disease () - Aug 2, 2021 - Abstract #AAIC2021AAIC_1941;
P1/2
Conclusions : IT bolus administration of multiple ascending doses of ISIS 814907 over 3 months was well-tolerated in patients with mild AD. The robust lowering of CSF total tau and phospho-tau warrants further investigation for the treatment of AD.
- || Aduhelm (aducanumab) / Eisai, Biogen, IONIS-MAPTRx / Ionis
Unlike mabs $biib 080 ASO removes not only extra cellular but also intra cellular #tau as well as all forms. #Aduhelm #AAIC21 #Alzheimers (Twitter) - Jul 27, 2021
- || IONIS-MAPTRx / Ionis
Clinical, P1 data: Phase 1b results confirm ISIS-814907 decrease of CSF total tau in mild AD patients #AAIC21 (Twitter) - Jul 27, 2021
- IONIS-MAPTRx / Biogen, Ionis
[VIRTUAL] BASELINE CHARACTERISTICS OF THE MILD ALZHEIMER’S DISEASE PATIENT POPULATION INCLUDED IN THE ONGOING RANDOMIZED, DOUBLE- BLIND, PLACEBO-CONTROLLED MULTIPLE ASCENDING DOSE PHASE 1B STUDY OF INTRATHECALLY ADMINISTERED TAU ANTISENSE OLIGONUCLEOTIDE (ISIS 814907; BIIB080) () - Aug 7, 2020 - Abstract #CTAD2020CTAD_73;
P1/2
The robust lowering of CSF total tau and phospho-tau warrants further investigation for the treatment of AD. The patients included in the study are reflective of a younger, mild AD population.
- | IONIS-MAPTRx / Ionis
Enrollment closed: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - Feb 7, 2020
P1/2, N=46, Active, not recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
The patients included in the study are reflective of a younger, mild AD population. Recruiting --> Active, not recruiting
- rasagiline / Generic mfg.
[VIRTUAL] ALZHEIMER’S DRUG DEVELOPMENT PIPELINE: NOVEL TARGETS AND INNOVATIVE APPROACHES (Hall E) - Jan 6, 2020 - Abstract #AATADPD2020AAT_ADPD_54;
One novel combination approach consists of losartan, amlodipine, atorvastatin and exercise and rasagiline is an example of molecule with pleiotropic effects on dopamine and disease-biology pathways...Novel designs being integrated into AD drug development include basket trials, randomized withdrawal trials, serial parallel comparison designs, and platform trials. Conclusions Progress in development of agents with novel targets and novel approaches will accelerate drug development for AD, clarify the disease-biology, and contribute to the development of treatments and treatment combinations for different phases of AD.
- | IONIS-MAPTRx / Ionis
Trial completion date, Trial primary completion date: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - Dec 23, 2019
P1/2, N=44, Recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Conclusions Progress in development of agents with novel targets and novel approaches will accelerate drug development for AD, clarify the disease-biology, and contribute to the development of treatments and treatment combinations for different phases of AD. Trial completion date: Feb 2020 --> May 2022 | Trial primary completion date: Jan 2020 --> May 2022
- | IONIS-MAPTRx / Ionis
New P1/2 trial: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - Jun 14, 2017
P1/2, N=44, Recruiting, Sponsor: Ionis Pharmaceuticals, Inc.