Trial Outcomes & Findings for A Study of the Effects of CY6463 in Participants With Alzheimer's Disease With Vascular Pathology (NCT NCT04798989)
NCT ID: NCT04798989
Last Updated: 2024-10-30
Results Overview
TEAE is defined as an adverse event with an onset that occurs after receiving the study drug, until the end of the Follow-up period
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
From first dose of study treatment through ~14 (±4) days after the final dose
Results posted on
2024-10-30
Participant Flow
Participants were randomized in a 1:1 ratio to receive either CY6463 or placebo.
Participant milestones
| Measure |
Placebo
Placebo once daily (QD) for approximately 87 sequential days.
|
CY6463
CY6463 QD for approximately 87 sequential days.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Effects of CY6463 in Participants With Alzheimer's Disease With Vascular Pathology
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Placebo QD for approximately 87 sequential days.
|
CY6463
n=6 Participants
CY6463 QD for approximately 87 sequential days.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment through ~14 (±4) days after the final doseTEAE is defined as an adverse event with an onset that occurs after receiving the study drug, until the end of the Follow-up period
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo QD for approximately 87 sequential days.
|
CY6463
n=6 Participants
CY6463 QD for approximately 87 sequential days.
|
|---|---|---|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) From Study Drug Initiation Through Follow-up
|
0 Participants
|
2 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CY6463
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Placebo QD for approximately 87 sequential days.
|
CY6463
n=6 participants at risk
CY6463 QD for approximately 87 sequential days.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From informed consent through ~14 (±4) days after the final dose. (Dosing ranged from 84 to 90 days for placebo and 85 to 91 days for CY6463).
|
16.7%
1/6 • From informed consent through ~14 (±4) days after the final dose. (Dosing ranged from 84 to 90 days for placebo and 85 to 91 days for CY6463).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From informed consent through ~14 (±4) days after the final dose. (Dosing ranged from 84 to 90 days for placebo and 85 to 91 days for CY6463).
|
16.7%
1/6 • From informed consent through ~14 (±4) days after the final dose. (Dosing ranged from 84 to 90 days for placebo and 85 to 91 days for CY6463).
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From informed consent through ~14 (±4) days after the final dose. (Dosing ranged from 84 to 90 days for placebo and 85 to 91 days for CY6463).
|
33.3%
2/6 • From informed consent through ~14 (±4) days after the final dose. (Dosing ranged from 84 to 90 days for placebo and 85 to 91 days for CY6463).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI may publish or disclose the results of the study 24 months after final data lock provided that sponsor can review the publication prior to public release, sponsor can request removal of confidential information of sponsor (not including results of trial), and sponsor can request a publication delay in order to protect potentially patentable information. Furthermore, if a publication committee is developing an initial publication, PI is to delay disclosure until that publication is published.
- Publication restrictions are in place
Restriction type: OTHER