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

Primary Purpose

Alzheimer Disease, Dementia, Cognition Disorders

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
SUVN-502
Sponsored by
Suven Life Sciences Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Alzheimer Disease focused on measuring SUVN-502, Expanded Access

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 28, 2018
    Last Updated
    September 25, 2020
    Sponsor
    Suven Life Sciences Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03564964
    Brief Title
    Expanded Access to Provide SUVN-502 for the Treatment of Subjects With Alzheimer's Disease
    Acronym
    SUVN-502
    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
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Suven Life Sciences Limited

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease, Dementia, Cognition Disorders
    Keywords
    SUVN-502, Expanded Access

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    SUVN-502
    Intervention Description
    Tablet

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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