Cognitive ImpairmentPhase 1NCT04051801
Multiple Ascending Dose Putative Cognitive Enhancer VU319
A Phase 1 study testing Dose Escalation of VU319 in people with Cognitive Impairment, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This is a safety study of the molecule VU319 to ascertain pharmacokinetic and pharmacodynamic data and test cognitive enhancement in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Dose Escalation of VU319
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2021to 25 May 2021
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 through 55 years, inclusive.
- Body mass index 18 through 32 kg/m2
- Determined as healthy based on screening medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG without clinically significant abnormalities. QTc interval with Fridericia's correction method recorded on screening and predose must be less than 450 msec for male and less than 470 in females.
- Clinical laboratory test result without clinically significant abnormalities at screening and at admission.
- Negative tests for Hepatitis B surface antigen, hepatitis C virus antibodies and human immunodeficiency virus (HIV-1 or HIV-2) antibody at screening.
- Nonsmokers (use of any nicotine containing product) or ex-smokers (have ceased smoking for at least 6 months and do not use any drug for smoking cessation).
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- Negative screen for drugs of abuse at screening and admission.
- Negative screen for alcohol at admission.
- For Women: Must have no child-bearing potential by reason of a sterilization procedure or at least 1 year post-menopausal (i.e. 12 months without menstrual period), or menopause confirmed with follicle-stimulating hormone level of > 30 IU/L at screening.
- For Men: Must be infertile (at least 3-months post-vasectomy), or truly abstinent of heterosexual intercourse, or heterosexual partner is not of child-bearing potential or must agree to use an effective method of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository) through the study and for 28 days after last dose of study drug.
- Able and willing to be available for the duration of the study.
- Willing and able to give written informed consent to participate.
- Able to understand and comply with protocol instructions.
- Agrees not to receive any vaccination within 21 days prior to admission and through Day 7 after final discharge.
- Agrees not to use nonprescription drugs, including vitamins, antacids, and herbal and dietary supplements within 7 days prior to admission and through 7 days after final discharge. Acetaminophen may be used at doses of ≤ 1 g/day, and ibuprofen may be used at doses of ≤ 1.2 g/day.
- Agrees not to use nicotine-containing products from screening through 48 hours after discharge.
- Agrees not to consume alcohol for the 72 hours prior to admission and through 48 hours after discharge.
- Agrees not to eat grapefruit or drink grapefruit juice within 7 days prior to admission and through 24 hours after discharge.
- Agrees to not drink caffeinated drinks from 72 hours prior to admission through discharge.
- Agrees not to eat or drink (except water) for 8 hours before and 4 hour after dosing for all MAD cohort subjects.
Who cannot join
- Individuals with significant previous or ongoing disease or disorder, based on history, physical exam, ECG, and laboratory tests, including for example: Cardiovascular diseases; hypertension; cancer or neoplasia; diabetes; hepatic, endocrine, metabolic, respiratory, renal, gastrointestinal (except appendectomy), dermatological or hematological disorders, Axis I or II psychiatric, substance use, or cognitive disorders.
- Clinically significant infection or inflammation at time of admission.
- Clinically significant abnormalities upon physical/neurological exam at screening.
- Acute gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) at admission
- History of treatment from a physician or counselor for abuse or misuse of alcohol, non-prescription drugs, medicinal drugs or other substance abuse.
- Any current or previous use of Class A drugs such as illicit opiate use, cocaine, ecstasy, LSD, and amphetamines (Class B). Volunteers that admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs-of-abuse test at screening and admission and have been abstinent for at least 3 months.
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- An alcoholic intake greater than 21 units per week or unwillingness to stop alcohol consumption for the duration of the study. Note: 1 unit = 8 g ethanol (250 mL of beer, 1 glass wine [100 mL], 1 measure spirits [30 mL]).
- Use of medication (including OTC and oral contraceptive agents) within 14 days of admission that may affect the safety of the subject or any study assessment, in the opinion of the investigator.
- Use of prescribed centrally active or psychoactive agents within 28 days prior to admission.
- Requirement for any medication that would need to be continued during the study.
- Use of any investigational medication within 3 months prior to the start of this study or scheduled to receive an investigational drug during the course of this study.
- Have participated in more than 2 clinical trials involving research medication use within the 12 months prior to screening.
- History of blood donation in the 2 months prior to admission.
- History of severe allergies or multiple adverse drug reactions.
- Any condition, which compromises ability to give informed consent or to communicate with the investigator as required for the completion of this study.
- The subject has been previously enrolled in the MAD study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Multiple Ascending Dose Phase I Study of the M1 Positive Allosteric Modulator VU0467319
This is a safety study of the molecule VU319 to ascertain pharmacokinetic and pharmacodynamic data and test cognitive enhancement in healthy volunteers.
Read the detailed description
Alzheimer's Disease (AD) is a chronic and irreversible neurodegenerative disease characterized by the deterioration of memory and other cognitive functions, progressive impairments in normal daily living, and severe neuropsychiatric symptoms and behavioral disturbances. Currently, there is no available prevention or cure for AD. Therapeutic strategies for the cognitive impairments in AD involve only symptomatic treatments, primarily through enhancement of cholinergic neurotransmission using AChEIs.
Primary objectives To establish the safety and tolerability of multiple dose (up to VU319 steady state) VU319 administration in healthy volunteers To establish the maximum tolerated dose of multiple dose (up to VU319 steady state) VU319 administration in healthy volunteers To characterize the plasma pharmacokinetics and urinary excretion of VU319 and metabolite after single dose oral administration in healthy volunteers Secondary objectives To establish the effect of food on the bioavailability and pharmacokinetic parameters of VU319 in healthy volunteers Exploratory Objectives To gain preliminary evidence that tolerable doses of VU319 engage central M1 receptors by 1) altering/enhancing cognitive performance, and 2) enhancing cortical event related potentials (ERP) as a measure of increased cognitive function in healthy volunteers
This will be a double blind, randomized, placebo controlled, and sequential dose escalation in male or female healthy volunteers. Gender will be balanced to the extent possible. Volunteers will receive oral VU319 multiple dose administration in the fasted state. Subjects meeting entry criteria will be enrolled in successive dose escalating cohorts of 8 subjects each (2 placebo and 6 active drug per dose level). The dose levels will be tested sequentially until the Maximum Tolerated Dose (MTD) is reached, or saturation of exposure occurs, or sustained VU319 plasma level above the safe daily exposure determined from animal toxicokinetic studies is achieved.
Clinical safety endpoints include adverse event and symptoms data, vital signs (HR, BP, Respiratory Rate, body weight), 12-lead ECG changes, and laboratory safety assessments (hematology, plasma biochemistry, coagulation, urinalysis).
- Conditions
- Cognitive Impairment
- Being tested
- Dose Escalation of VU319, Dose Escalation of 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.
Dose Escalation of VU319Drug
dose levels of the cohorts will be increased step wise
Dose Escalation of PlaceboDrug
dose levels of the cohorts will be increased step wise
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation of VU319 - Dose 1 | Experimental | Not described Receives: Drug: Dose Escalation of VU319; Drug: Dose Escalation of Placebo |
| Dose Escalation of Placebo - Dose 1 | Placebo comparator | Not described Receives: Drug: Dose Escalation of VU319; Drug: Dose Escalation of Placebo |
| Dose Escalation of VU319 - Dose 2 | Experimental | Not described Receives: Drug: Dose Escalation of VU319; Drug: Dose Escalation of Placebo |
| Dose Escalation of Placebo - Dose 2 | Placebo comparator | Not described Receives: Drug: Dose Escalation of VU319; Drug: Dose Escalation of Placebo |
| Dose Escalation of VU319 - Dose 3 | Experimental | Not described Receives: Drug: Dose Escalation of VU319; Drug: Dose Escalation of Placebo |
| Dose Escalation of Placebo - Dose 3 | Placebo comparator | Not described Receives: Drug: Dose Escalation of VU319; Drug: Dose Escalation of Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence of Treatment-Emergent Adverse Events
Measured: Changes in adverse events frequency from Baseline to 144 hours post last drug administration
Secondary outcomes (17)
Cognitive Battery - Critical Flicker Fusion (CFF)
The Critical Flicker Fusion (CFF) task will be used as a test of vigilance. The primary dependent measures are ascending and descending fusion frequency (Hz).
Measured: Baseline, 1 hours post last drug administration
Cognitive Battery - Choice Reaction Time (CRT)
The Choice Reaction Time (CRT) task from the Milford Test Battery will be used to examine psychomotor functions. The dependent measures are the median total reaction time (RT), and its subcomponents of recognition RT, motor RT.
Measured: Baseline, 1 hours post last drug administration
Cognitive Battery - Spatial Selective Attention (Posner Task)
This task measures response speed corresponding to a validly and invalidly cued stimulus. The cue will be valid 57% of the time, and for the other 43% will be equiprobable as an invalid cue, a neutral cue showing pointing to both sides, or a no cue condition. The two outcome measures will be difference scores between the cues. The first is the alerting effect (neutral - no cue trials). The second is the reorienting effect (valid - invalid trials).
Measured: Baseline, 1 hours post last drug administration
Cognitive Battery - Continuous Performance Test (Conners)
The Conners Continuous Performance Task (CPT) will be used to measure sustained attention. The dependent measures are omission and commission errors, hit reaction time, hit RT standard error (SE).
Measured: Baseline, 1 hours post last drug administration
Cognitive Battery - Working Memory (N-Back Test)
The N-Back Test will be used as a test of verbal working memory. The dependent measures are sensitivity (d') and bias (C) across load conditions (0-3 back).
Measured: Baseline, 1 hours post last drug administration
Cognitive Battery - The Selective Reminding Task (SRT)
The Selective Reminding Task (SRT) is a multi-trial verbal list-learning task allowing the examination of acquisition, encoding and retrieval. This standard test has been widely used in studies of cognitive impairment and offers measures of storage into and retrieval from both short term and long-term memory and intrusion errors. The dependent measures are immediate total (8 trials) word recall, recall failure, recall consistency and delayed recall.
Measured: Baseline, 1 hours post last drug administration
Cognitive Battery - Trail Making Task
The Trail Making Task is a neuropsychological test of visual attention and task switching. The dependent measurement will be the difference in completion time between Trails B and Trails A.
Measured: Baseline, 1 hours post last drug administration
Event-Related Potentials- Incidental Memory Tasks
Change in late positive potential (P300-600) amplitude over frontal, central, and parietal midline locations (Fz, Cz, Pz) for repeated vs novel stimuli.
Measured: Baseline, 2.5 hours post last drug administration
Event-Related Potentials- Auditory and Visual Oddball Tasks
Change in P300 amplitude over frontal, central, and parietal midline locations (Fz, Cz, Pz) for target vs standard stimuli.
Measured: Baseline, 2.5 hours post last drug administration
Quantitative EEG
A passive 3 minutes resting-EEG paradigm, with two blocks, one with eyes closed, the other with eyes open. The dependent variable for this paradigm will be changes in power of frequency bands from 2-30 Hz between baseline and post-dose testing sessions.
Measured: Baseline, 2.5 hours post last drug administration
Behavioral Measure - Profile of Mood State (POMS)
The Profile of Mood States (POMS) measures six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. A five-point scale ranging from "not at all" to "extremely" is administered by experimenters to patients to assess their mood states.
Measured: Baseline, 1 hours post last drug administration
Behavioral Measure - Brief Psychiatric Rating Scale (BPRS)
Brief Psychiatric Rating Scale (BPRS) assesses the level of 24 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. It is particularly useful in gauging the efficacy of treatment in patients who have moderate to severe psychoses. It is based on the clinician's observations of the patient's behavior. The rater enters a number for each symptom construct that ranges from 1 (not present) to 7 (extremely severe).
Measured: Baseline, 1 hours post last drug administration
Behavioral Measure - Subject Visual Analogue Scale (SVAS)
Subject Visual Analog Scales (SVAS) will be used consisting of a series of items such as "drowsiness" or "psychomotor agitation" scored on 100 mm lines scored by the subject.
Measured: Baseline, 1 hours post last drug administration
Behavioral Measure - Stanford Sleepiness Scale
To collect a spectrum of sleepiness indicators across a day, the SSS is administered at two-hour intervals. The SSS uses the following numeric scale:
- Feeling active, vital, alert, and wide awake.
- Functioning at a high level but not at peak performance. Able to concentrate.
- Relaxed and awake, but not fully alert. Still responsive.
- Feeling a little foggy and let down.
- Foggy and beginning to lose track of things. Difficult to stay awake.
- Sleepy and prefer to lie down. Woozy.
- Almost in reverie and cannot stay awake. Sleep onset is imminent.
Measured: Baseline, 0.5 hour pre each drug administration and 23.5 hour post last drug administration
Behavioral Measure - Physical Symptom Checklist
A checklist of 22 physical symptoms. Each item is rated 1 to 4, with 1 being none and 4 being severe. Total score range from 22 to 88.
Measured: Baseline, 0.5 hour pre each drug administration and 23.5 hour post last drug administration
Actigraphy
Starting at day -1, each subject will receive a wearable motion-based actigraphy device for assessing sleep (sleep duration and patterns of deep and light sleep stages) and biometrics. The device incorporates clinical-grade photoplethysmography (PPG) technology to capture physiological biometric data, including heart rate (HR), heart rate variability (HRV), respiratory rate(RR), and blood oxygen saturation (SPO2).
Measured: Day-1 (Baseline) to Day 8 (23.5 hour post last drug administration)
Behavioral Measure-Suicide Behavior Questionnaire (SBQ-R)
It consists of four questions. Each of the four questions addresses a specific risk factor: the first concerns presence of suicidal thoughts and attempts, the second concerns frequency of suicidal thoughts, the third concerns the threat level of suicidal attempts, and the fourth concerns likelihood of future suicidal attempts. The first item has often been used on its own in order to assign individuals to a suicidal and a non-suicidal control group for studies. A total score of 7 and higher in the general population and a total score of 8 and higher in patients with psychiatric disorders indicates significant risk of suicidal behavior.
Measured: Day 8 (23.5 hour post last drug administration), Day 12(144 hours post last drug administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start25 May 2021
- Primary completion25 May 2021
- Study completion25 May 2021
Why it stopped: Further development has been outlicensed to Acadia Pharmaceuticals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Newhouse, Vanderbilt University Medical Center
- Investigators
- Paul A Newhouse, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051801
- Sponsor's protocol ID
- 190919
- Status last verified
- May 2021
- First submitted
- 19 Jul 2019
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Ascending Dose Phase I Study of the M1 Positive Allosteric Modulator VU0467319
- ClinicalTrials.gov ID
- NCT04051801
- Acronym / sponsor ID
- 190919
- Conditions
- Cognitive Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Further development has been outlicensed to Acadia Pharmaceuticals
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 9 Aug 2019 (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 safety study of the molecule VU319 to ascertain pharmacokinetic and pharmacodynamic data and test cognitive enhancement in healthy volunteers.
Detailed description
Alzheimer's Disease (AD) is a chronic and irreversible neurodegenerative disease characterized by the deterioration of memory and other cognitive functions, progressive impairments in normal daily living, and severe neuropsychiatric symptoms and behavioral disturbances. Currently, there is no available prevention or cure for AD. Therapeutic strategies for the cognitive impairments in AD involve only symptomatic treatments, primarily through enhancement of cholinergic neurotransmission using AChEIs.
Primary objectives To establish the safety and tolerability of multiple dose (up to VU319 steady state) VU319 administration in healthy volunteers To establish the maximum tolerated dose of multiple dose (up to VU319 steady state) VU319 administration in healthy volunteers To characterize the plasma pharmacokinetics and urinary excretion of VU319 and metabolite after single dose oral administration in healthy volunteers Secondary objectives To establish the effect of food on the bioavailability and pharmacokinetic parameters of VU319 in healthy volunteers Exploratory Objectives To gain preliminary evidence that tolerable doses of VU319 engage central M1 receptors by 1) altering/enhancing cognitive performance, and 2) enhancing cortical event related potentials (ERP) as a measure of increased cognitive function in healthy volunteers
This will be a double blind, randomized, placebo controlled, and sequential dose escalation in male or female healthy volunteers. Gender will be balanced to the extent possible. Volunteers will receive oral VU319 multiple dose administration in the fasted state. Subjects meeting entry criteria will be enrolled in successive dose escalating cohorts of 8 subjects each (2 placebo and 6 active drug per dose level). The dose levels will be tested sequentially until the Maximum Tolerated Dose (MTD) is reached, or saturation of exposure occurs, or sustained VU319 plasma level above the safe daily exposure determined from animal toxicokinetic studies is achieved.
Clinical safety endpoints include adverse event and symptoms data, vital signs (HR, BP, Respiratory Rate, body weight), 12-lead ECG changes, and laboratory safety assessments (hematology, plasma biochemistry, coagulation, urinalysis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation of VU319 - Dose 1 | Experimental | Drug: Dose Escalation of VU319, Drug: Dose Escalation of Placebo |
| Dose Escalation of Placebo - Dose 1 | Placebo comparator | Drug: Dose Escalation of VU319, Drug: Dose Escalation of Placebo |
| Dose Escalation of VU319 - Dose 2 | Experimental | Drug: Dose Escalation of VU319, Drug: Dose Escalation of Placebo |
| Dose Escalation of Placebo - Dose 2 | Placebo comparator | Drug: Dose Escalation of VU319, Drug: Dose Escalation of Placebo |
| Dose Escalation of VU319 - Dose 3 | Experimental | Drug: Dose Escalation of VU319, Drug: Dose Escalation of Placebo |
| Dose Escalation of Placebo - Dose 3 | Placebo comparator | Drug: Dose Escalation of VU319, Drug: Dose Escalation of Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Men and women aged 18 through 55 years, inclusive.
- Body mass index 18 through 32 kg/m2
- Determined as healthy based on screening medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG without clinically significant abnormalities. QTc interval with Fridericia's correction method recorded on screening and predose must be less than 450 msec for male and less than 470 in females.
- Clinical laboratory test result without clinically significant abnormalities at screening and at admission.
- Negative tests for Hepatitis B surface antigen, hepatitis C virus antibodies and human immunodeficiency virus (HIV-1 or HIV-2) antibody at screening.
Key exclusion criteria (16 listed)
- Individuals with significant previous or ongoing disease or disorder, based on history, physical exam, ECG, and laboratory tests, including for example: Cardiovascular diseases; hypertension; cancer or neoplasia; diabetes; hepatic, endocrine, metabolic, respiratory, renal, gastrointestinal (except appendectomy), dermatological or hematological disorders, Axis I or II psychiatric, substance use, or cognitive disorders.
- Clinically significant infection or inflammation at time of admission.
- Clinically significant abnormalities upon physical/neurological exam at screening.
- Acute gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) at admission
- History of treatment from a physician or counselor for abuse or misuse of alcohol, non-prescription drugs, medicinal drugs or other substance abuse.
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 |
|---|---|---|
| Dose Escalation of VU319dose levels of the cohorts will be increased step wise | Drug | Dose Escalation of Placebo - Dose 1, Dose Escalation of Placebo - Dose 2, Dose Escalation of Placebo - Dose 3, Dose Escalation of VU319 - Dose 1, Dose Escalation of VU319 - Dose 2, Dose Escalation of VU319 - Dose 3 |
| Dose Escalation of Placebodose levels of the cohorts will be increased step wise | Drug | Dose Escalation of Placebo - Dose 1, Dose Escalation of Placebo - Dose 2, Dose Escalation of Placebo - Dose 3, Dose Escalation of VU319 - Dose 1, Dose Escalation of VU319 - Dose 2, Dose Escalation of VU319 - Dose 3 |
Primary outcome
Safety and Tolerability
Time frame: Changes in adverse events frequency from Baseline to 144 hours post last drug administration
Incidence of Treatment-Emergent Adverse Events
17 secondary outcomes
Cognitive Battery - Critical Flicker Fusion (CFF)
Time frame: Baseline, 1 hours post last drug administration
Cognitive Battery - Choice Reaction Time (CRT)
Time frame: Baseline, 1 hours post last drug administration
Cognitive Battery - Spatial Selective Attention (Posner Task)
Time frame: Baseline, 1 hours post last drug administration
Cognitive Battery - Continuous Performance Test (Conners)
Time frame: Baseline, 1 hours post last drug administration
Cognitive Battery - Working Memory (N-Back Test)
Time frame: Baseline, 1 hours post last drug administration
Cognitive Battery - The Selective Reminding Task (SRT)
Time frame: Baseline, 1 hours post last drug administration
Cognitive Battery - Trail Making Task
Time frame: Baseline, 1 hours post last drug administration
Event-Related Potentials- Incidental Memory Tasks
Time frame: Baseline, 2.5 hours post last drug administration
Event-Related Potentials- Auditory and Visual Oddball Tasks
Time frame: Baseline, 2.5 hours post last drug administration
Quantitative EEG
Time frame: Baseline, 2.5 hours post last drug administration
Behavioral Measure - Profile of Mood State (POMS)
Time frame: Baseline, 1 hours post last drug administration
Behavioral Measure - Brief Psychiatric Rating Scale (BPRS)
Time frame: Baseline, 1 hours post last drug administration
Behavioral Measure - Subject Visual Analogue Scale (SVAS)
Time frame: Baseline, 1 hours post last drug administration
Behavioral Measure - Stanford Sleepiness Scale
Time frame: Baseline, 0.5 hour pre each drug administration and 23.5 hour post last drug administration
Behavioral Measure - Physical Symptom Checklist
Time frame: Baseline, 0.5 hour pre each drug administration and 23.5 hour post last drug administration
Actigraphy
Time frame: Day-1 (Baseline) to Day 8 (23.5 hour post last drug administration)
Behavioral Measure-Suicide Behavior Questionnaire (SBQ-R)
Time frame: Day 8 (23.5 hour post last drug administration), Day 12(144 hours post last drug administration)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
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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.
Paul A Newhouse, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dose Escalation of VU319 in people with Cognitive Impairment, run by Vanderbilt University Medical Center at 1 site in United States.
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 20 inclusion and 16 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: withdrawn, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Safety and Tolerability (time frame: Changes in adverse events frequency from Baseline to 144 hours post last drug administration). 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 28 May 2021.