Phase 2
N=113
Nutraceutical Effects on Long-Term Memory
Aging
Bottom Line
View on ClinicalTrials.gov: NCT01963767 ↗Enrolled (actual)
113
Serious AEs
1.0%
Results posted
Jul 2014
Primary outcome: Primary: Delay Eyeblink Conditioning — 52.32; 56.88 percentage of conditioned responses
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NT-020 (Drug); Placebo (Dietary_supplement)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delay Eyeblink Conditioning |
52.32; 56.88 | — |
| SECONDARY Cognitive Performance |
24.12; 21.72 | .03 sig |
Summary
Interventions to improve the cognitive health of older adults are of critical importance. In the current protocol, ithe investigators conducted a short-term (two months) randomized clinical trial to examine the influence of the nutraceutical NT-020 on the cognitive performance of older adults. Participants were tested with a battery of cognitive tasks at baseline and two months after being randomized to the interventional drug or placebo.
Eligibility Criteria
Inclusion Criteria
- Adults 65-85 years of age (inclusive).
- Able to understand and sign the informed consent.
- Native English-speaking.
- No evidence of dementia (MMSE >=23).
- Each subject must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts.
- All subjects must be willing to be monitored for adequacy of nutritional intake during the intervention, as is the current standard of clinical practice.
Exclusion Criteria
- Use of high dose antioxidant supplements other than what is provided in the trial.
- History of known allergy to components of the study supplements.
- Mental illness judged by the PI to preclude a successful completion of the trial.
- Persons who are not native English speakers are excluded from the current proposal because many of the cognitive tests that are administered are language-based and are heavily influenced by first language.
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Data sourced from ClinicalTrials.gov (NCT01963767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.