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Expanded Access to Provide SUVN-502 for the Treatment of Subjects With Alzheimer's Disease (SUVN-502)

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ClinicalTrials.gov Identifier: NCT03564964
Expanded Access Status : Available
First Posted : June 21, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Suven Life Sciences Limited

Brief Summary:

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to SUVN-502 for the treatment of Alzheimer's Disease. Investigator as well as the subject/caregiver must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the patient's medical history and program eligibility criteria.

Subjects will not be evaluated for efficacy and safety during the expanded access.


Condition or disease Intervention/treatment
Alzheimer Disease Dementia Cognition Disorders Drug: SUVN-502

Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: An Intermediate-Size, Expanded Access to SUVN-502 for the Treatment of Subjects With Alzheimer's Disease Who Have Completed the CTP2S1502HT6 Study



Intervention Details:
  • Drug: SUVN-502
    Tablet

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Subjects who have completed the 30 week treatment period of study CTP2S1502HT6 as planned and wish to continue treatment with SUVN-502.
  • Subject (or subject's legally acceptable representative) and caregiver must sign the Informed Consent Form (ICF) to participate in the study.

Exclusion Criteria:

  • Has participated or is participating in any other clinical (investigational) study after completion of CTP2S1502HT6 study.
  • Is treated or likely to require treatment during the study with any medication prohibited by this expanded access program.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564964


Contacts
Contact: Ramakrishna Nirogi +91 9392483002 suvn502study@suven.com

Sponsors and Collaborators
Suven Life Sciences Limited

Responsible Party: Suven Life Sciences Limited
ClinicalTrials.gov Identifier: NCT03564964     History of Changes
Other Study ID Numbers: EAP1502HT6
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Keywords provided by Suven Life Sciences Limited:
SUVN-502
Expanded Access

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders