* Phase 1b Study SDI-118 in Elderly Participants With Cognitive Decline
Research type
Research Study
Full title
A Phase 1b, Exploratory, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline.
IRAS ID
301096
Contact name
Amin Boateng
Contact email
Sponsor organisation
Syndesi Therapeutics SA
Eudract number
2021-000965-33
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
Summary of Research
This is a research study for participants between 65 and 85 years of age whom either themselves or an informant (e.g. family member, personal friend) believes the participant has had cognitive decline associated with aging, for example, a decline in memory processing speed, memory recollection and attention.The purpose of this study is to evaluate the safety and tolerability of a study medicine, SDI-118, in patients with cognitive decline, and to determine how the participants ability to think and reason is influenced by SDI-118 in comparison to a placebo.
The sponsor of this study is Syndesi Therapeutics SA. The study is taking place in the United Kingdom (UK) and Germany.
Study participants will be randomized in a 1:1 ratio into 1 of 2 treatment arms (30 study participants each) and perform cognitive tasks inside and outside an MRI scanner. Study participants will be allocated to either 5 mg SDI-118 or matching placebo QD for 17 (±1) days. The total duration for each study participant is approximately 9 weeks, including the Screening Period (up to 28 days), Treatment Period (17 [±1] days), and a Safety Follow-Up Visit (Day 31 [±2 days]). There will be a total of 7 study visits.
Summary of Results
"No formal statistical analysis of the safety data was conducted.
No neurophysiologic and cognitive assessment conclusions were drawn.
No exploratory conclusions were drawn.
The Sponsor decided to discontinue the study on 10 March 2022. This discontinuation was not due to any safety or other concern regarding conduct of the study.
There were no deaths, treatment-emergent severe AEs, treatment-emergent SAEs, or TEAEs that led to withdrawal from the study or study drug."REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/FT/0077
Date of REC Opinion
16 Jul 2021
REC opinion
Further Information Favourable Opinion