Reliability of Standardized IQ Testing Under Modafinil, Racetam-Class Compounds, Sleep Restriction and Daily Activity

NCT07852130 | Completed Phase 1

• 1 other identifier: ReserologyRF1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy; Cognition; Sleep Deprivation

Keywords

Modafinil; Racetams; Oxiracetam; Pramiracetam; Phenylpiracetam; Aniracetam; Psychometric reliability; Response initiation; Sleep restriction; Cognitive enhancement; Standard error of measurement; Practice effects

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (month 0), monthly interim assessments (months 1-5), and endpoint (month 6).

Secondary Outcomes (3)

• Observer-coded hesitation (response initiation interval)

  At each of seven in-person assessment sessions over six months, under rested and sleep-restricted conditions

• Total response latency

  At each of seven in-person assessment sessions over six months, under rested and sleep-restricted conditions

• Post-initiation execution time

  At each of seven in-person assessment sessions over six months, under rested and sleep-restricted conditions

Other Outcomes (1)

• Association between wearable-derived daily activity and standardized cognitive test performance

  Continuously across the six-month study period

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: Aniracetam; Other: Sleep restriction

Interventions

Modafinil DRUG

Administered orally, pre-test, at each of seven assessment sessions over six months. Dose not recorded in the source report.

Modafinil

Oxiracetam DRUG

Administered orally, pre-test, at 100, 200 or 300 mg/day across the six-month study period.

Oxiracetam

Pramiracetam DRUG

Administered orally, pre-test, at 100, 200 or 300 mg/day across the six-month study period.

Pramiracetam

Phenylpiracetam DRUG

Administered orally, pre-test, at 100, 200 or 300 mg/day across the six-month study period.

Phenylpiracetam

Aniracetam DRUG

Administered orally, pre-test, at 100, 200 or 300 mg/day across the six-month study period.

Aniracetam

Inert matched preparation (placebo) OTHER

Inert matched preparation administered orally, pre-test, at each assessment session.

Also known as: Placebo

Placebo

Sleep restriction OTHER

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.

Aniracetam; Modafinil; Oxiracetam; Phenylpiracetam; Placebo; Pramiracetam

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Current illness at the time of assessment
• Any illness or medical condition disclosed at screening

Sponsors & Collaborators

• Abdulraheem Mohamed Gouda: lead

Study Sites (1)

Reserology Research Foundation

London, United Kingdom

Location

Related Publications (12)

• 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.

  PMID: 32709551 BACKGROUND

• Kredlow 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.

  PMID: 31433334 BACKGROUND

• Turner 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.

  PMID: 12417966 BACKGROUND

• Muller 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.

  PMID: 15221200 BACKGROUND

• Repantis 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.

  PMID: 20416377 BACKGROUND

• Randall 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.

  PMID: 16140369 BACKGROUND

• Gouhie 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.

  PMID: 38878641 BACKGROUND

• Zhang 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.

  PMID: 37898393 BACKGROUND

• McLean 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.

  PMID: 1786500 BACKGROUND

• Garrett 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.

  PMID: 39242965 BACKGROUND

• Estevis 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.

  PMID: 22353021 BACKGROUND

• Basso 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.

  PMID: 11992227 BACKGROUND

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Modafinil; oxiracetam; pramiracetam; aniracetam

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Rashed

  Reserology Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Placebo participants received an inert matched preparation. Participants and assessors were blinded to treatment assignment where operationally feasible, and treatment identity was not disclosed during cognitive scoring. The circumstances in which blinding was not maintained are not specified in the source report, and modafinil produces noticeable subjective alerting effects, so the study is described as placebo-controlled and partially blinded rather than double-blind.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lead Researcher

Model Details: 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.

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: October 1, 2026
• Study Start: March 9, 2026
• Primary Completion: September 9, 2026
• Study Completion: September 12, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)