N/A
Completed N=10
KNA Proof-of-Concept
Adherence, Treatment · Retention · Cognitive Impairment, Mild
Source: ClinicalTrials.gov NCT04968041 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Ketogenic Adherence — 8 Participants
Summary
The intervention program proof-of-concept was assessed as a single-arm, within-subjects clinical study with a target enrollment of 10 participants with possible or probable amnestic MCI. The protocol required participants to complete a pre-intervention assessment within two weeks of beginning the intervention, attend seven, one-hour intervention group sessions across six weeks, complete a post-assessment and interview in the final week of the intervention, and complete weekly surveys throughout the intervention.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ketogenic Adherence |
8 | — |
| PRIMARY Acceptability |
3; 1; 5 | — |
| PRIMARY Retention |
9 | — |
| SECONDARY Cognitive Functioning |
97.11 | — |
Eligibility Criteria
Inclusion Criteria
- Final inclusion criteria included individuals who met criteria for "possible" Mild cognitive impairment (MCI), which was defined as the following: evidence of either subjective decline in memory and greater self-reported use of compensatory strategies OR poorer performance than expected in one or more cognitive domain OR limited evidence of impairment in both subjective and objective findings.
Exclusion Criteria
- Presence of severe and/or unstable medical conditions
- diagnosable major neurocognitive disorder
Data sourced from ClinicalTrials.gov (NCT04968041). 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. Informational only — not medical advice.