Cognitive DeclinePhase 1NCT05199142
A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline
A Phase 1 study testing SDI-118 in people with Cognitive Decline, run by Syndesi Therapeutics at 2 sites in 2 countries.
Trial summary
This is a multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on elderly male and female study participants with cognitive decline at screening. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- SDI-118
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Sep 2021to 11 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male and female study participants between 65 and 85 years of age (inclusive) at screening, with cognitive decline, defined as:
- >25 on the MMSE;
- <11 on the GDS; and
- IQCODE score of ≥52.
- Participants with delayed recall of ≤6 words from the ISLT 15 minutes after the presentation of the word list;
- Must be in good health for their age as determined by medical history, physical examinations, 12-lead ECGs, vital signs, and clinical laboratory assessments (serum chemistry, serum hematology, and urinalysis) performed at the Screening Visit;
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- Must have an informant (eg, spouse, family member, caregiver, or other close contact) who has known the study participant for at least 10 years to provide data on the study participant;
- Negative serology tests for HIV antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at screening;
- Have a body mass index of 18 to 36 kg/m2 inclusive;
- Agree not to use herbal medications (including herbal tea, St. John's Wort), within 14 days prior to study drug administration to the Safety Follow-Up Visit (Visit 7);
- Agree not to use previously prescribed medications that are expected to interfere with the absorption, distribution, metabolism, and/or excretion (ie, strong cytochrome P450 3A4 or 2C19 inhibitors or inducers, LEV, and brivaracetam) or safety/tolerability evaluation of SDI-118 or that could interfere with the objectives of the study (ie, medications with CNS activity);
- Participants must have signed an informed consent document indicating that the participants understand the purpose of, and procedures required for the study, and are willing to participate in the study;
- Smokers are allowed if their average daily consumption does not exceed 5 cigarettes per day (or maximum equivalent of 5 cigarettes per day);
- Non-vasectomized male participants with a female partner of childbearing potential must agree to use a condom from first dosing up to 90 days after the last dose. Additionally, the female partner must be willing to use a highly effective method of contraception;
- Female participants must have confirmed menopause;
- The participant, in the opinion of the Investigator, is willing and able to adhere to the study visit schedule and other requirements, prohibitions, and restrictions of the study.
Who cannot join
- Are left-handed;
- Have, or have a history within the last 12 months of, drug or alcohol dependency or positive urine drug screen or alcohol breath test at Screening or Assessment Visits;
- History, or presence upon clinical examination, of cardiac, ophthalmologic, pulmonary, endocrine (uncontrolled diabetes), cancer, blood disease, gastrointestinal, hepatic, renal disease, or other condition that, in the opinion of the Investigator, could interfere with the test procedures;
- History or presence of significant neurological or psychiatric conditions such as stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, or blackouts requiring hospitalization;
- History of, or current condition of, migraine headaches;
- Have undergone operations to the brain;
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- Have significant visual impairment including color blindness, history of ocular treatment including corrective laser eye surgery, or ongoing condition that, in the opinion of the Investigator, may interfere with the performance of the cognitive test battery;
- Participants who consume large amounts of caffeinated drinks (more than 8 cups of standard caffeinated drinks [eg, tea, instant coffee] or 6 cups of stronger coffee or other drinks containing methylxanthines such as soda or energy drinks per day);
- Have received an experimental drug and/or used an experimental medical device within 30 days of the Screening Visit or within 5 half-lives, whichever is longer;
- Are unable to comply with MRI Patient Declaration;
- Have a resting pulse <45 bpm or >100 bpm at Screening or on Day 1;
- Participants with any of the following findings in the resting ECG:
- Fridericia-corrected QT interval >450 ms (males); >470 ms (females); or <300 ms at Screening or on Day 1; or
- Wolff-Parkinson-White syndrome, complete left bundle branch block (LBBB).
- Family history of congenital long QT syndrome or sudden death;
- Poorly controlled diabetes (hemoglobin A1c >8.5%);
- Poorly controlled hypertension (systolic blood pressure >155 mmHg and diastolic blood pressure >95 mmHg);
- Diagnosed with anemia (defined as hemoglobin <12 g/dL);
- Have reduced renal function defined as having an estimated glomerular filtration rate (eGFR) of <59 mL/min/1.73 m²;
- Have physical, language, or other impairments of such severity as to adversely affect the validity of the data derived from the cognitive tasks as judged by the Investigator;
- Any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 3 months prior to screening or at Screening or Baseline Visits;
- Unable to comply with MRI or blood draw procedures (suffers from claustrophobia or needle phobia);
- Known clinically relevant structural brain abnormality as determined by previous MRI or persistent MRI imaging artefact which is judged to produce extensive imaging distortions (eg, extensive dental work) as determined at the Imaging Baseline Visit (Visit 2, Day 0); or
- With a disease or take any medication that, in the Investigator's and/or Sponsor's opinion, could interfere with the assessments of safety, tolerability, or pharmacodynamics as well as the conduct or interpretation of the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official 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
This is a multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on elderly male and female study participants with cognitive decline at screening.
- Conditions
- Cognitive Decline
- Being tested
- SDI-118, Placebo
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDI-118Drug
SDI-118 Powder in Capsules (PiC) are presented as Drug Substance in white, size 3, hydroxypropylmethylcellulose (HPMC) capsules. No excipients are added.
PlaceboDrug
The Matching Placebo for SDI-118 PiC is equivalent dose of mannitol (an inert excipient) in white, size 3, hydroxypropylmethylcellulose (HPMC) capsules.
| Study group | Role | What they receive |
|---|---|---|
| SDI-118 | Experimental | SDI-118 capsule self-administered orally once daily (QD) for 17 days. Receives: Drug: SDI-118 |
| Placebo | Placebo comparator | Placebo capsule self-administered orally once daily (QD) for 17 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
Measured: 17 days
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values (hematology/chemistry/urinalysis).
Measured: 17 days
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values.
Measured: 17 days
Number of participants with routine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant ECG values.
Measured: 17 days
Number of participants with C-SSRS abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in C-SSRS values.
Measured: 17 days
Number of participants with routine physical examination abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in physical examination.
Measured: 17 days
Number of participants with Changes in the Cogstate Brief Battery, including abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in the Cogstate Brief Battery values.
Measured: 17 days
Number of participants with Changes in the Digital Symbol Substitution Test, including abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in the DSST values.
Measured: 17 days
Number of participants with Changes in the Controlled Oral Word Association Test, including abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in the COWAT values.
Measured: 17 days
Number of participants with Changes in the Category Fluency Test, including abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in the CFT values.
Measured: 17 days
Secondary outcomes (2)
Changes in Blood Oxygen Level Dependent (BOLD) signal
As measured by changes in deoxyhemoglobin levels driven by localized changes in brain blood flow and blood oxygenation in brain networks associated with executive function (working memory), including the prefrontal cortex, the hippocampus, and the associated limbic networks, during performance of the N-Back Tasks
Measured: 17 days
Performance measures associated with executive function (working memory) during the N-Back Tasks
As measured by both response accuracy and response latency between cue stimulus and detection of this cue in the presented trial stimuli
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start23 Sep 2021
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
Why it stopped: Development plan changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syndesi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199142
- Sponsor's protocol ID
- SYND005
- Status last verified
- Apr 2022
- First submitted
- 30 Nov 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05199142
- Acronym / sponsor ID
- SYND005
- Conditions
- Cognitive Decline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development plan changed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Syndesi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on elderly male and female study participants with cognitive decline at screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDI-118 | Experimental | Drug: SDI-118SDI-118 capsule self-administered orally once daily (QD) for 17 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule self-administered orally once daily (QD) for 17 days. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- Male and female study participants between 65 and 85 years of age (inclusive) at screening, with cognitive decline, defined as:
- Participants with delayed recall of ≤6 words from the ISLT 15 minutes after the presentation of the word list;
- Must be in good health for their age as determined by medical history, physical examinations, 12-lead ECGs, vital signs, and clinical laboratory assessments (serum chemistry, serum hematology, and urinalysis) performed at the Screening Visit;
- Must have an informant (eg, spouse, family member, caregiver, or other close contact) who has known the study participant for at least 10 years to provide data on the study participant;
- Negative serology tests for HIV antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at screening;
Key exclusion criteria (24 listed)
- Are left-handed;
- Have, or have a history within the last 12 months of, drug or alcohol dependency or positive urine drug screen or alcohol breath test at Screening or Assessment Visits;
- History, or presence upon clinical examination, of cardiac, ophthalmologic, pulmonary, endocrine (uncontrolled diabetes), cancer, blood disease, gastrointestinal, hepatic, renal disease, or other condition that, in the opinion of the Investigator, could interfere with the test procedures;
- History or presence of significant neurological or psychiatric conditions such as stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, or blackouts requiring hospitalization;
- History of, or current condition of, migraine headaches;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDI-118SDI-118 Powder in Capsules (PiC) are presented as Drug Substance in white, size 3, hydroxypropylmethylcellulose (HPMC) capsules. No excipients are added. | Drug | SDI-118 |
| PlaceboThe Matching Placebo for SDI-118 PiC is equivalent dose of mannitol (an inert excipient) in white, size 3, hydroxypropylmethylcellulose (HPMC) capsules. | Drug | Placebo |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: 17 days
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant laboratory values (hematology/chemistry/urinalysis).
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant vital sign values.
Number of participants with routine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant ECG values.
Number of participants with C-SSRS abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant changes in C-SSRS values.
Number of participants with routine physical examination abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant changes in physical examination.
Number of participants with Changes in the Cogstate Brief Battery, including abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant changes in the Cogstate Brief Battery values.
Number of participants with Changes in the Digital Symbol Substitution Test, including abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant changes in the DSST values.
Number of participants with Changes in the Controlled Oral Word Association Test, including abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant changes in the COWAT values.
Number of participants with Changes in the Category Fluency Test, including abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant changes in the CFT values.
2 secondary outcomes
Changes in Blood Oxygen Level Dependent (BOLD) signal
Time frame: 17 days
Performance measures associated with executive function (working memory) during the N-Back Tasks
Time frame: 17 days
Results and safety
The study was stopped early (reason given: Development plan changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SDI-118 in people with Cognitive Decline, run by Syndesi Therapeutics at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Development plan changed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs) (time frame: 17 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.