Racetam research medicine · Fact sheet
Aniracetam
Also known as Ro 13-5057
Aniracetam is a racetam studied in older dementia trials. Results are mixed: a 109-person study reported benefits, while a 44-person trial found no clinical advantage and more confusion-related interruptions in the active group.
What is Aniracetam?
Aniracetam has been investigated for modulation of excitatory neurotransmission. That mechanism does not establish cognitive benefit.
Studies in people with dementia cannot establish enhancement in healthy adults.
Benefits & claims
Readers encounter Aniracetam in discussions of cognition, mood or mental fatigue. The relevant study population and outcome determine whether those claims are supported.
What the evidence supports
- The 109-person six-month study reported differences favoring aniracetam.
- In the 44-person three-month trial, both groups improved on some tests and clinical efficacy did not differ.
- The inconsistent results do not establish reliable everyday memory enhancement.
Research areas
- Cognition and memory
- Neurologic or psychiatric research
Dosage & frequency
Human study contextThe original human study supplies an exposure reference, not an established cognitive-enhancement regimen.
44-person double-blind Alzheimer-type dementia study
Older patients with Alzheimer-type dementia
- Amount
- 1 g
- Frequency
- Daily for three months
- Route studied or labeled
- Oral
This trial found no clinical efficacy difference from placebo; confusion led to more interruptions in the active group. It does not supply a healthy-person regimen.
How to read these amounts
An approved regimen belongs to a specific product, indication, and population. A study regimen describes what researchers tested; it does not establish a prescription or a safe self-use protocol. Products, routes, and formulations are not interchangeable. A prescriber uses the full label and individual clinical circumstances.
Personal accounts may describe amounts, schedules and outcomes beyond clinical research. They do not establish a regimen. Read the reported experiences
Formulations, interactions & practical context
- Identity and pharmacology
- Aniracetam has been investigated for modulation of excitatory neurotransmission. That mechanism does not establish cognitive benefit.
Formulation differences
- Studies in people with dementia cannot establish enhancement in healthy adults.
Interactions & precautions
- The reviewed sources do not establish a comprehensive human interaction profile for this exact substance or combination.
What is still unresolved
- Reproducible benefit on everyday function in the intended population
- Long-term safety and clinically important interactions
- Equivalence of nonstandard products to research formulations
Side effects & risks
- Treatment was interrupted for confusion in four aniracetam recipients and one placebo recipient in the 44-person trial.
- Long-term safety and interactions outside the studied older populations remain uncertain.
This is a summary of the cited evidence, not a complete product label. A lack of human safety data does not establish safety.
Clinical research
Early human evidenceThe older controlled studies differ in design, duration and outcomes. An open comparative study provides weaker causal evidence than a randomized placebo-controlled trial.
Studies
109-person six-month placebo-controlled dementia study.
44-person trial; no clinical efficacy difference and confusion-related interruptions.
Open study; allocation and comparison limitations.
Personal experiences
Reports describe what someone noticed. They cannot establish cause, typical results, or how often a side effect happens. Amounts and schedules describe the individual account, not an effective or safe dose. Product identity and strength may be unverified, and missing details are left explicit.
No attributable personal accounts were found in the sources reviewed.
Approval status
Aniracetam is not an FDA-approved treatment for the cognitive or mood uses discussed here. Regional use, historical trials and online availability are separate from U.S. drug approval.
No FDA-approved product for this entry
Approval covers the labeled product, use and population. A trial phase does not establish success; a stopped program is not ongoing research.
- Aniracetam (Ro 13-5057) in the treatment of senile dementia of Alzheimer type (SDAT): results of a placebo controlled multicentre clinical study.
- Senile dementia of the Alzheimer type treated with aniracetam: a new nootropic agent.
- Aniracetam comparative open study
- FDA warning letter: unapproved nootropic claims
Open questions
- Reproducible benefit on everyday function in the intended population
- Long-term safety and clinically important interactions
- Equivalence of nonstandard products to research formulations
Summary
The inconsistent results do not establish reliable everyday memory enhancement.
Sources
Medical evidence and regulatory sources are listed here. Personal reports are linked separately in the experiences section.
- pubmedAniracetam (Ro 13-5057) in the treatment of senile dementia of Alzheimer type (SDAT): results of a placebo controlled multicentre clinical study.
109-person six-month placebo-controlled dementia study.
- pubmedSenile dementia of the Alzheimer type treated with aniracetam: a new nootropic agent.
44-person trial; no clinical efficacy difference and confusion-related interruptions.
- fdaFDA warning letter: unapproved nootropic claims
FDA identifies unapproved drug claims for named nootropics; this is an enforcement letter, not efficacy evidence.