Back to resultsExpanded 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
About this trial
This is an expanded access trial for Alzheimer Disease focused on measuring SUVN-502, Expanded Access
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03564964
First Posted
May 28, 2018
Last Updated
September 25, 2020
Sponsor
Suven Life Sciences Limited
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
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Primary Completion Date
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Study Completion Date
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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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