XanaCIDD: Assessing safety, tolerability and efficacy of Xanamem in adults with CIDD
Research type
Research Study
Full title
Protocol Title: XanaCIDD: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Assess the Safety, Tolerability, and Efficacy of Xanamem® in Adults with Cognitive Impairment due to Depressive Disorder.
IRAS ID
1007376
Contact name
Lee Bergman
Contact email
Sponsor organisation
Actinogen Medical
Eudract number
2023-000030-15
Clinicaltrials.gov Identifier
Research summary
This study will test the safety and tolerability (how well the body tolerates) of Xanamem in adults with clinical depression, with ongoing symptoms of low mood and some difficulty with thinking or memory. The study will also test the effectiveness (how well it works) of Xanamem on symptoms that happen with depression, such as sadness and loss of pleasure, tiredness, loss of energy, and difficulty concentrating and thinking. The study will take place at up to 4 sites in the UK, as well as 11 sites in Australia. Approximately 160 participants will take part in the study. Participants will be assigned by chance to 1 of 2 treatment groups of equal size - Xanamem or placebo. Neither the participants, the study doctor, or the sponsor of the study will know which group participants are in (called a randomised, double-blind study). Participants will take part in the trial for up to 14 weeks. This includes a screening period of up to 4 weeks, a treatment period of 6 weeks, and a follow-up period of 4 weeks. Participants will have several safety tests done at visits to the study site, such as checking blood pressure and heart rate, physical examination, and blood tests. They will also take several questionnaires and tests to measure their thinking and memory.
REC name
Wales REC 1
REC reference
23/WA/0069
Date of REC Opinion
21 Aug 2023
REC opinion
Further Information Favourable Opinion