HealthyPhase 1NCT07852130
Reliability of Standardized IQ Testing Under Modafinil, Racetam-Class Compounds, Sleep Restriction and Daily Activity
A Phase 1 study testing Modafinil, Oxiracetam and Pramiracetam in people with Healthy and Cognition, run by Abdulraheem Mohamed Gouda at 1 site in United Kingdom.
Trial summary
This study examined whether standardized IQ test scores in healthy adults aged 18-35 are stable measures of cognitive ability and evaluated whether standardized cognitive-test performance and response-initiation measures vary across pharmacological and sleep conditions. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Cognition, Sleep Deprivation
- What is being tested?
- Modafinil, Oxiracetam and Pramiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Mar 2026to 12 Sep 2026
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteer
- Aged 18 to 35 years
- Able to attend seven in-person assessment sessions over six months
- Willing to wear a consumer wearable device continuously across the study period
- In relatively good general health
Who cannot join
- Current illness at the time of assessment
- Any illness or medical condition disclosed at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Reliability of IQ Tests in Various Populations As a Result of Fluctuating Brain Plasticity, Administered Racetam-Class Drugs, Intelligence Placebos, Daily Energy Levels, and Modafinil
This study examined whether standardized IQ test scores in healthy adults aged 18-35 are stable measures of cognitive ability and evaluated whether standardized cognitive-test performance and response-initiation measures vary across pharmacological and sleep conditions. Seventy healthy volunteers were assessed at seven in-person timepoints over six months, with 25 participants receiving an inert matched preparation and 45 receiving modafinil or one of four racetam-class compounds (oxiracetam, pramiracetam, phenylpiracetam, aniracetam) administered orally before testing. A different standardized instrument was administered at each timepoint to limit item-level recall and practice effects, and change in the placebo group was used as the reference for estimating practice effects. Participants were assessed under both rested and sleep-restricted conditions, two psychologists were present at every administration to code response initiation (hesitation), and physiological state was monitored using a consumer wearable. Psychometric changes were evaluated relative to the standard error of measurement of the instruments and the study's prespecified minimum detectable effect. Response-initiation measures were analysed separately from psychometric scores to evaluate potential effects on response initiation and execution time.
Read the detailed description
Design. Placebo-controlled, repeated-measures study with seven in-person assessment timepoints over six months: baseline at month 0, five monthly interim assessments, and endpoint at month 6. Allocation to placebo or active treatment followed a computer-generated sequence stratified by age group (18-25 versus 26-35). Twenty-five participants received an inert matched preparation; 45 were distributed across five active conditions, approximately nine participants per compound.
Interventions. All compounds were administered orally before testing. Racetam conditions used 100, 200 and 300 mg/day. The modafinil dose administered is not recorded in the available source report and remains an outstanding data item.
Instruments. A different standardized instrument was administered at each timepoint, drawn from the Wechsler Adult Intelligence Scale, the Stanford-Binet Intelligence Scales Fifth Edition, the Woodcock-Johnson Tests of Cognitive Abilities, and Raven's Advanced Progressive Matrices. Scores were converted to standardized units before aggregation because the instruments differ in maximum attainable score.
Observational measure. Hesitation was operationally defined as the interval between presentation of the decision stimulus and initiation of the participant's committed response. It was coded by two psychologists under standardized conditions, computed from multiple valid trials per participant, and aggregated to participant-level means before analysis. Trials with technical failures and responses outside the prespecified valid-response window were excluded.
Sleep condition. Participants were assessed under both rested and sleep-restricted conditions, classified against a predefined sleep-duration threshold, with sleep duration recorded before each assessment.
Physiological monitoring. Wearable monitoring using an Apple Watch Series 11 was conducted throughout the study period. Daily activity variables derived from this dataset were analysed separately from randomized treatment effects.
Analysis. A mixed-effects model was specified with treatment condition, assessment time, sleep condition and relevant interactions as fixed effects, participant as a random effect, and age (continuous) and baseline cognitive performance as adjustment variables. Change in the placebo group was used as the reference for estimating practice effects. Dose-response was tested for monotonic trend and treated as exploratory. Response-initiation latency and post-initiation execution time were analysed as separate observational measures.
Measurement and power considerations. With approximately nine participants per active condition, the study was designed to detect only very large effects, with an estimated minimum detectable standardized effect of approximately d=1.2 or greater. Psychometric changes were evaluated relative to the standard error of measurement of the instruments and the study's minimum detectable effect.
Expectancy component. The original protocol specified an intelligence-placebo (expectancy) manipulation. The expectancy component was not implemented and is not included as an outcome of the present analysis.
- Conditions
- Healthy, Cognition, Sleep Deprivation
- Being tested
- Modafinil, Oxiracetam, Pramiracetam, Phenylpiracetam, Aniracetam
- Keywords
- Modafinil, Racetams, Oxiracetam, Pramiracetam, Phenylpiracetam, Aniracetam, Psychometric reliability, Response initiation, Sleep restriction, Cognitive enhancement, Standard error of measurement, Practice effects
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
Administered orally, pre-test, at each of seven assessment sessions over six months. Dose not recorded in the source report.
OxiracetamDrug
Administered orally, pre-test, at 100, 200 or 300 mg/day across the six-month study period.
PramiracetamDrug
Administered orally, pre-test, at 100, 200 or 300 mg/day across the six-month study period.
PhenylpiracetamDrug
Administered orally, pre-test, at 100, 200 or 300 mg/day across the six-month study period.
AniracetamDrug
Administered orally, pre-test, at 100, 200 or 300 mg/day across the six-month study period.
Inert matched preparation (placebo)Other
Also called Placebo
Inert matched preparation administered orally, pre-test, at each assessment session.
Sleep restrictionOther
Participants were assessed under both rested and sleep-restricted conditions. Sessions were classified against a predefined sleep-duration threshold, and sleep duration was recorded before each cognitive assessment. The numerical threshold is an outstanding data item in the source report.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Twenty-five participants received an inert matched preparation orally before each assessment. Change observed in this group served as the practice-effect reference for all treatment comparisons. Receives: Other: Inert matched preparation (placebo); Other: Sleep restriction |
| Modafinil | Experimental | Oral modafinil administered pre-test at each assessment session. The dose administered and the number of participants allocated to this condition are outstanding data items in the source report. Receives: Drug: Modafinil; Other: Sleep restriction |
| Oxiracetam | Experimental | Oral oxiracetam 100, 200 or 300 mg/day administered pre-test. This range is approximately 8 to 20 times below published human dosing regimens, so results in this condition do not constitute a test of the compound's cognitive efficacy. Receives: Drug: Oxiracetam; Other: Sleep restriction |
| Pramiracetam | Experimental | Oral pramiracetam 100, 200 or 300 mg/day administered pre-test. This range is approximately 4 to 12 times below published human dosing regimens, so results in this condition do not constitute a test of the compound's cognitive efficacy. Receives: Drug: Pramiracetam; Other: Sleep restriction |
| Phenylpiracetam | Experimental | Oral phenylpiracetam 100, 200 or 300 mg/day administered pre-test. This is the only racetam condition dosed within the published human range (50 to 200 mg/day, typically 100 mg once or twice daily), and therefore the only racetam condition with plausibly meaningful exposure. Receives: Drug: Phenylpiracetam; Other: Sleep restriction |
| Aniracetam | Experimental | Oral aniracetam 100, 200 or 300 mg/day administered pre-test. This range is approximately 5 to 15 times below published human dosing regimens, so results in this condition do not constitute a test of the compound's cognitive efficacy. Receives: Drug: Aniracetam; Other: Sleep restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response initiation latency measured by psychologist-coded stimulus-to-committed-response interval
Mean response initiation latency, measured as the interval between presentation of the decision stimulus and initiation of the participant's committed response. Latency will be coded by two psychologists from multiple valid trials under standardized testing conditions and aggregated to a participant-level mean.
Measured: Baseline (month 0), monthly interim assessments (months 1-5), and endpoint (month 6).
Secondary outcomes (3)
Observer-coded hesitation (response initiation interval)
Interval in seconds between presentation of the decision stimulus and initiation of the participant's committed response, coded by two psychologists present at every administration. Computed from multiple valid trials per participant and aggregated to participant-level means. Trials containing technical failures and responses outside the prespecified valid-response window were excluded.
Measured: At each of seven in-person assessment sessions over six months, under rested and sleep-restricted conditions
Total response latency
Total interval in seconds from stimulus presentation to completion of the response, timed by the attending psychologists.
Measured: At each of seven in-person assessment sessions over six months, under rested and sleep-restricted conditions
Post-initiation execution time
Total response latency minus hesitation, in seconds. Derived from the reported means rather than measured independently.
Measured: At each of seven in-person assessment sessions over six months, under rested and sleep-restricted conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start9 Mar 2026
- Primary completion9 Sep 2026
- Study completion12 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were allocated to a placebo condition or to one of five active compound conditions and assessed repeatedly at seven in-person timepoints over six months. Each participant was additionally observed under rested and sleep-restricted conditions. Whether the rested and sleep-restricted observations were obtained within or between participants is an outstanding data item in the source report.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdulraheem Mohamed Gouda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdulraheem Mohamed Gouda, Reserology Research Foundation
- Investigators
- Rashed, Principal investigator, Reserology Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852130
- Sponsor's protocol ID
- ReserologyRF1
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No repository, access mechanism or data use agreement process exists for this cohort.
Publications
Roberts CA, Jones A, Sumnall H, Gage SH, Montgomery C. How effective are pharmaceuticals for cognitive enhancement in healthy adults? A series of meta-analyses of cognitive performance during acute administration of modafinil, methylphenidate and D-amphetamine. Eur Neuropsychopharmacol. 2020 Sep;38:40-62. doi: 10.1016/j.euroneuro.2020.07.002. Epub 2020 Jul 21.
PubMed 32709551Kredlow MA, Keshishian A, Oppenheimer S, Otto MW. The Efficacy of Modafinil as a Cognitive Enhancer: A Systematic Review and Meta-Analysis. J Clin Psychopharmacol. 2019 Sep/Oct;39(5):455-461. doi: 10.1097/JCP.0000000000001085.
PubMed 31433334Turner DC, Robbins TW, Clark L, Aron AR, Dowson J, Sahakian BJ. Cognitive enhancing effects of modafinil in healthy volunteers. Psychopharmacology (Berl). 2003 Jan;165(3):260-9. doi: 10.1007/s00213-002-1250-8. Epub 2002 Nov 1.
PubMed 12417966Muller U, Steffenhagen N, Regenthal R, Bublak P. Effects of modafinil on working memory processes in humans. Psychopharmacology (Berl). 2004 Dec;177(1-2):161-9. doi: 10.1007/s00213-004-1926-3. Epub 2004 Jun 24.
PubMed 15221200Repantis D, Schlattmann P, Laisney O, Heuser I. Modafinil and methylphenidate for neuroenhancement in healthy individuals: A systematic review. Pharmacol Res. 2010 Sep;62(3):187-206. doi: 10.1016/j.phrs.2010.04.002. Epub 2010 Apr 21.
PubMed 20416377Randall DC, Shneerson JM, File SE. Cognitive effects of modafinil in student volunteers may depend on IQ. Pharmacol Biochem Behav. 2005 Sep;82(1):133-9. doi: 10.1016/j.pbb.2005.07.019. Epub 2005 Sep 2.
PubMed 16140369Gouhie FA, Barbosa KO, Cruz ABR, Wellichan MM, Zampolli TM. Cognitive effects of piracetam in adults with memory impairment: A systematic review and meta-analysis. Clin Neurol Neurosurg. 2024 Aug;243:108358. doi: 10.1016/j.clineuro.2024.108358. Epub 2024 May 31.
PubMed 38878641Zhang T, Tao Y, Pu J, Zhu M, Wan L, Tang C. Safety, tolerability, and pharmacokinetics of oral (S)-oxiracetam in Chinese healthy volunteers: A randomized, double-blind, controlled phase I study. Eur J Pharm Sci. 2024 Jan 1;192:106621. doi: 10.1016/j.ejps.2023.106621. Epub 2023 Oct 28.
PubMed 37898393McLean A Jr, Cardenas DD, Burgess D, Gamzu E. Placebo-controlled study of pramiracetam in young males with memory and cognitive problems resulting from head injury and anoxia. Brain Inj. 1991 Oct-Dec;5(4):375-80. doi: 10.3109/02699059109008110.
PubMed 1786500Garrett J, Chak C, Bullock T, Giesbrecht B. A systematic review and Bayesian meta-analysis provide evidence for an effect of acute physical activity on cognition in young adults. Commun Psychol. 2024 Aug 28;2(1):82. doi: 10.1038/s44271-024-00124-2.
PubMed 39242965Estevis E, Basso MR, Combs D. Effects of practice on the Wechsler Adult Intelligence Scale-IV across 3- and 6-month intervals. Clin Neuropsychol. 2012;26(2):239-54. doi: 10.1080/13854046.2012.659219. Epub 2012 Feb 21.
PubMed 22353021Basso MR, Carona FD, Lowery N, Axelrod BN. Practice effects on the WAIS-III across 3- and 6-month intervals. Clin Neuropsychol. 2002 Feb;16(1):57-63. doi: 10.1076/clin.16.1.57.8329.
PubMed 11992227
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Reliability of IQ Tests in Various Populations As a Result of Fluctuating Brain Plasticity, Administered Racetam-Class Drugs, Intelligence Placebos, Daily Energy Levels, and Modafinil
- ClinicalTrials.gov ID
- NCT07852130
- Acronym / sponsor ID
- ReserologyRF1
- Conditions
- Healthy, Cognition, Sleep Deprivation
- Keywords
- Modafinil, Racetams, Oxiracetam, Pramiracetam, Phenylpiracetam, Aniracetam, Psychometric reliability, Response initiation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Abdulraheem Mohamed GoudaUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 12 Sep 2026 (actual)
- First posted
- 1 Oct 2026 (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 study examined whether standardized IQ test scores in healthy adults aged 18-35 are stable measures of cognitive ability and evaluated whether standardized cognitive-test performance and response-initiation measures vary across pharmacological and sleep conditions. Seventy healthy volunteers were assessed at seven in-person timepoints over six months, with 25 participants receiving an inert matched preparation and 45 receiving modafinil or one of four racetam-class compounds (oxiracetam, pramiracetam, phenylpiracetam, aniracetam) administered orally before testing. A different standardized instrument was administered at each timepoint to limit item-level recall and practice effects, and change in the placebo group was used as the reference for estimating practice effects. Participants were assessed under both rested and sleep-restricted conditions, two psychologists were present at every administration to code response initiation (hesitation), and physiological state was monitored using a consumer wearable. Psychometric changes were evaluated relative to the standard error of measurement of the instruments and the study's prespecified minimum detectable effect. Response-initiation measures were analysed separately from psychometric scores to evaluate potential effects on response initiation and execution time.
Detailed description
Design. Placebo-controlled, repeated-measures study with seven in-person assessment timepoints over six months: baseline at month 0, five monthly interim assessments, and endpoint at month 6. Allocation to placebo or active treatment followed a computer-generated sequence stratified by age group (18-25 versus 26-35). Twenty-five participants received an inert matched preparation; 45 were distributed across five active conditions, approximately nine participants per compound.
Interventions. All compounds were administered orally before testing. Racetam conditions used 100, 200 and 300 mg/day. The modafinil dose administered is not recorded in the available source report and remains an outstanding data item.
Instruments. A different standardized instrument was administered at each timepoint, drawn from the Wechsler Adult Intelligence Scale, the Stanford-Binet Intelligence Scales Fifth Edition, the Woodcock-Johnson Tests of Cognitive Abilities, and Raven's Advanced Progressive Matrices. Scores were converted to standardized units before aggregation because the instruments differ in maximum attainable score.
Observational measure. Hesitation was operationally defined as the interval between presentation of the decision stimulus and initiation of the participant's committed response. It was coded by two psychologists under standardized conditions, computed from multiple valid trials per participant, and aggregated to participant-level means before analysis. Trials with technical failures and responses outside the prespecified valid-response window were excluded.
Sleep condition. Participants were assessed under both rested and sleep-restricted conditions, classified against a predefined sleep-duration threshold, with sleep duration recorded before each assessment.
Physiological monitoring. Wearable monitoring using an Apple Watch Series 11 was conducted throughout the study period. Daily activity variables derived from this dataset were analysed separately from randomized treatment effects.
Analysis. A mixed-effects model was specified with treatment condition, assessment time, sleep condition and relevant interactions as fixed effects, participant as a random effect, and age (continuous) and baseline cognitive performance as adjustment variables. Change in the placebo group was used as the reference for estimating practice effects. Dose-response was tested for monotonic trend and treated as exploratory. Response-initiation latency and post-initiation execution time were analysed as separate observational measures.
Measurement and power considerations. With approximately nine participants per active condition, the study was designed to detect only very large effects, with an estimated minimum detectable standardized effect of approximately d=1.2 or greater. Psychometric changes were evaluated relative to the standard error of measurement of the instruments and the study's minimum detectable effect.
Expectancy component. The original protocol specified an intelligence-placebo (expectancy) manipulation. The expectancy component was not implemented and is not included as an outcome of the present analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- Participants were allocated to a placebo condition or to one of five active compound conditions and assessed repeatedly at seven in-person timepoints over six months. Each participant was additionally observed under rested and sleep-restricted conditions. Whether the rested and sleep-restricted observations were obtained within or between participants is an outstanding data item in the source report.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Inert matched preparation (placebo), Other: Sleep restrictionTwenty-five participants received an inert matched preparation orally before each assessment. Change observed in this group served as the practice-effect reference for all treatment comparisons. |
| Modafinil | Experimental | Drug: Modafinil, Other: Sleep restrictionOral modafinil administered pre-test at each assessment session. The dose administered and the number of participants allocated to this condition are outstanding data items in the source report. |
| Oxiracetam | Experimental | Drug: Oxiracetam, Other: Sleep restrictionOral oxiracetam 100, 200 or 300 mg/day administered pre-test. This range is approximately 8 to 20 times below published human dosing regimens, so results in this condition do not constitute a test of the compound's cognitive efficacy. |
| Pramiracetam | Experimental | Drug: Pramiracetam, Other: Sleep restrictionOral pramiracetam 100, 200 or 300 mg/day administered pre-test. This range is approximately 4 to 12 times below published human dosing regimens, so results in this condition do not constitute a test of the compound's cognitive efficacy. |
| Phenylpiracetam | Experimental | Drug: Phenylpiracetam, Other: Sleep restrictionOral phenylpiracetam 100, 200 or 300 mg/day administered pre-test. This is the only racetam condition dosed within the published human range (50 to 200 mg/day, typically 100 mg once or twice daily), and therefore the only racetam condition with plausibly meaningful exposure. |
| Aniracetam | Experimental | Drug: Aniracetam, Other: Sleep restrictionOral aniracetam 100, 200 or 300 mg/day administered pre-test. This range is approximately 5 to 15 times below published human dosing regimens, so results in this condition do not constitute a test of the compound's cognitive efficacy. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult volunteer
- Aged 18 to 35 years
- Able to attend seven in-person assessment sessions over six months
- Willing to wear a consumer wearable device continuously across the study period
- In relatively good general health
Key exclusion criteria (2 listed)
- Current illness at the time of assessment
- Any illness or medical condition disclosed at screening
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 |
|---|---|---|
| ModafinilAdministered orally, pre-test, at each of seven assessment sessions over six months. Dose not recorded in the source report. | Drug | Modafinil |
| OxiracetamAdministered orally, pre-test, at 100, 200 or 300 mg/day across the six-month study period. | Drug | Oxiracetam |
| PramiracetamAdministered orally, pre-test, at 100, 200 or 300 mg/day across the six-month study period. | Drug | Pramiracetam |
| PhenylpiracetamAdministered orally, pre-test, at 100, 200 or 300 mg/day across the six-month study period. | Drug | Phenylpiracetam |
| AniracetamAdministered orally, pre-test, at 100, 200 or 300 mg/day across the six-month study period. | Drug | Aniracetam |
| Inert matched preparation (placebo)Also: PlaceboInert matched preparation administered orally, pre-test, at each assessment session. | Other | Placebo |
| Sleep restrictionParticipants were assessed under both rested and sleep-restricted conditions. Sessions were classified against a predefined sleep-duration threshold, and sleep duration was recorded before each cognitive assessment. The numerical threshold is an outstanding data item in the source report. | Other | Aniracetam, Modafinil, Oxiracetam, Phenylpiracetam, Placebo, Pramiracetam |
Primary outcome
Response initiation latency measured by psychologist-coded stimulus-to-committed-response interval
Time frame: Baseline (month 0), monthly interim assessments (months 1-5), and endpoint (month 6).
Mean response initiation latency, measured as the interval between presentation of the decision stimulus and initiation of the participant's committed response. Latency will be coded by two psychologists from multiple valid trials under standardized testing conditions and aggregated to a participant-level mean.
3 secondary outcomes
Observer-coded hesitation (response initiation interval)
Time frame: At each of seven in-person assessment sessions over six months, under rested and sleep-restricted conditions
Total response latency
Time frame: At each of seven in-person assessment sessions over six months, under rested and sleep-restricted conditions
Post-initiation execution time
Time frame: At each of seven in-person assessment sessions over six months, under rested and sleep-restricted conditions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 32709551Roberts CA, Jones A, Sumnall H, Gage SH, Montgomery C. How effective are pharmaceuticals for cognitive enhancement in healthy adults? A series of meta-analyses of cognitive performance during acute administration of modafinil, methylphenidate and D-amphetamine. Eur Neuropsychopharmacol. 2020 Sep;38:40-62. doi: 10.1016/j.euroneuro.2020.07.002. Epub 2020 Jul 21.
- Background: PubMed 31433334Kredlow MA, Keshishian A, Oppenheimer S, Otto MW. The Efficacy of Modafinil as a Cognitive Enhancer: A Systematic Review and Meta-Analysis. J Clin Psychopharmacol. 2019 Sep/Oct;39(5):455-461. doi: 10.1097/JCP.0000000000001085.
- Background: PubMed 12417966Turner DC, Robbins TW, Clark L, Aron AR, Dowson J, Sahakian BJ. Cognitive enhancing effects of modafinil in healthy volunteers. Psychopharmacology (Berl). 2003 Jan;165(3):260-9. doi: 10.1007/s00213-002-1250-8. Epub 2002 Nov 1.
- Background: PubMed 15221200Muller U, Steffenhagen N, Regenthal R, Bublak P. Effects of modafinil on working memory processes in humans. Psychopharmacology (Berl). 2004 Dec;177(1-2):161-9. doi: 10.1007/s00213-004-1926-3. Epub 2004 Jun 24.
- Background: PubMed 20416377Repantis D, Schlattmann P, Laisney O, Heuser I. Modafinil and methylphenidate for neuroenhancement in healthy individuals: A systematic review. Pharmacol Res. 2010 Sep;62(3):187-206. doi: 10.1016/j.phrs.2010.04.002. Epub 2010 Apr 21.
- Background: PubMed 16140369Randall DC, Shneerson JM, File SE. Cognitive effects of modafinil in student volunteers may depend on IQ. Pharmacol Biochem Behav. 2005 Sep;82(1):133-9. doi: 10.1016/j.pbb.2005.07.019. Epub 2005 Sep 2.
- Background: PubMed 38878641Gouhie FA, Barbosa KO, Cruz ABR, Wellichan MM, Zampolli TM. Cognitive effects of piracetam in adults with memory impairment: A systematic review and meta-analysis. Clin Neurol Neurosurg. 2024 Aug;243:108358. doi: 10.1016/j.clineuro.2024.108358. Epub 2024 May 31.
- Background: PubMed 37898393Zhang T, Tao Y, Pu J, Zhu M, Wan L, Tang C. Safety, tolerability, and pharmacokinetics of oral (S)-oxiracetam in Chinese healthy volunteers: A randomized, double-blind, controlled phase I study. Eur J Pharm Sci. 2024 Jan 1;192:106621. doi: 10.1016/j.ejps.2023.106621. Epub 2023 Oct 28.
- Background: PubMed 1786500McLean A Jr, Cardenas DD, Burgess D, Gamzu E. Placebo-controlled study of pramiracetam in young males with memory and cognitive problems resulting from head injury and anoxia. Brain Inj. 1991 Oct-Dec;5(4):375-80. doi: 10.3109/02699059109008110.
- Background: PubMed 39242965Garrett J, Chak C, Bullock T, Giesbrecht B. A systematic review and Bayesian meta-analysis provide evidence for an effect of acute physical activity on cognition in young adults. Commun Psychol. 2024 Aug 28;2(1):82. doi: 10.1038/s44271-024-00124-2.
- Background: PubMed 22353021Estevis E, Basso MR, Combs D. Effects of practice on the Wechsler Adult Intelligence Scale-IV across 3- and 6-month intervals. Clin Neuropsychol. 2012;26(2):239-54. doi: 10.1080/13854046.2012.659219. Epub 2012 Feb 21.
- Background: PubMed 11992227Basso MR, Carona FD, Lowery N, Axelrod BN. Practice effects on the WAIS-III across 3- and 6-month intervals. Clin Neuropsychol. 2002 Feb;16(1):57-63. doi: 10.1076/clin.16.1.57.8329.
- Individual participant dataSharing planned: No. No repository, access mechanism or data use agreement process exists for this cohort.
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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.
Rashed principal investigator
Reserology Research Foundation
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 Modafinil, Oxiracetam and Pramiracetam in people with Healthy and Cognition, run by Abdulraheem Mohamed Gouda at 1 site in United Kingdom.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 1 Oct 2026. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response initiation latency measured by psychologist-coded stimulus-to-committed-response interval (time frame: Baseline (month 0), monthly interim assessments (months 1-5), and endpoint (month 6).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07852130, which also lists 12 linked publications.
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 1 Oct 2026.