Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777409
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2021-02-26
Brief Title:
A Research Study Investigating Semaglutide in People With Early Alzheimers Disease EVOKE Plus
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimers Disease EVOKE Plus
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is done to find out whether the medicine semaglutide has a positive effect on early Alzheimers disease
Participants will either get semaglutide or placebo a dummy medicine which does not contain any study medicine - which treatment participants get is decided by an equal chance
The study will last for up to 173 weeks about 3 years and 4 months Participants will have 17 clinic visits and 1 phone call with the study doctor The study includes various tests and scans At 10 of the clinic visits participants will have blood samples taken
Participants must have a study partner who is willing to take part in the study
Women cannot take part if pregnant breastfeeding or plan to become pregnant during the study period
A cerebrospinal fluid CSF sub-study will be performed as a part of the study The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study The endpoints related to this sub-study are exploratory only
Participants will either get semaglutide or placebo a dummy medicine which does not contain any study medicine - which treatment participants get is decided by an equal chance
The study will last for up to 173 weeks about 3 years and 4 months Participants will have 17 clinic visits and 1 phone call with the study doctor The study includes various tests and scans At 10 of the clinic visits participants will have blood samples taken
Participants must have a study partner who is willing to take part in the study
Women cannot take part if pregnant breastfeeding or plan to become pregnant during the study period
A cerebrospinal fluid CSF sub-study will be performed as a part of the study The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study The endpoints related to this sub-study are exploratory only
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1259-2920 | OTHER | None | None |
| 2020-004864-25 | REGISTRY | European Medicines Agency EudraCT | None |