A two-part, randomized, two-period, two-sequence crossover and placebo-controlled parallel group, phase 1B trial to evaluate the safety and pharmacokinetics of Modafinil administered in combination with Aniracetam in elderly subjects with subjective cognitive decline

A two-part, randomized, two-period, two-sequence crossover and placebo-controlled parallel group, phase 1B trial to evaluate the safety and pharmacokinetics of Modafinil administered in combination with Aniracetam in elderly subjects with subjective cognitive decline - Safety of Modafinil & aniracetam in healthy elderly with cognitive decline

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48229

Enrollment

Registered

2019-09-11

Start date

2019-09-13

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjective cognitive decline

Interventions

Part 1: Treatment A: modafinil 200 mg and 2 empty capsules once a day for 7 days Treatment B: modafinil 200 mg with aniracetam 1500 mg once a day for 7 days Part 2: Modafinil 200 mg and aniracetam

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female with subjective cognitive decline 65 - 85 years of age BMI 19.0 - 35.0 kilograms/meter2

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. Donation or loss of more than 100 mL of blood within 60 days prior to the first drug administration.

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of modafinil, administered in combination with aniracetam, in generally healthy elderly male and female subjects with subjective cognitive decline (SCD)	—

Secondary

Measure	Time frame
To evaluate the pharmacokinetics (PK) of modafinil, administered alone or in combination with aniracetam, in older generally healthy male and female subjects with SCD.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)