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

Sponsor
Suven Life Sciences Limited (Industry)
Overall Status
No longer available
CT.gov ID
NCT03564964
Collaborator
(none)

Study Details

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Suven Life Sciences Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suven Life Sciences Limited
    ClinicalTrials.gov Identifier:
    NCT03564964
    Other Study ID Numbers:
    • EAP1502HT6
    First Posted:
    Jun 21, 2018
    Last Update Posted:
    Sep 29, 2020
    Last Verified:
    Sep 1, 2020
    Keywords provided by Suven Life Sciences Limited
    SUVN-502
    Expanded Access
    Additional relevant MeSH terms:
    Alzheimer Disease
    Cognition Disorders
    1-((2-bromophenyl)sulfonyl)-5-methoxy-3-((4-methyl-1-piperazinyl)methyl)-1H-indole dimesylate monohydrate

    Study Results

    No Results Posted as of Sep 29, 2020