2026-09-17
critical
Phase changed: not applicable → Phase 1/2
Primary endpoint(s) modified1 entry, revised
WasEvaluate the safety of a six-month FMD intervention
NowEvaluate and compare the safety of an approximately 8-week FMD or low dose rapamycin intervention relative to a matched control group
Enrollment increased: 40 → 60 participants
Trial arms changed: 2 → 3
Primary completion pushed: 2027-03 → 2028-03
Completion pushed: 2027-03 → 2028-06
Interventions modified
2026-02-04
notable
Recruiting→Not Yet Recruiting Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusRecruiting→Not Yet Recruiting
Primary completion date2026-11→2027-03
Completion date2026-11→2027-03
Start date2024-11→2026-03
Enrollment target60→40
InterventionsFMD1 (LNT22-017-1) (Dietary Supplement)→Dietary Guidance (Behavioral), FMD1 (LNT22-017-1) (Dietary Supplement)
Eligibility criteria-10 characters
[...] the APOE e4 allele
BMI 20-39kg/m2 (inclusive) at screening
On a stable medication regimen for at least 3 months.
Exclusion Criteria:
Has any medical disease or condition tha [...] ay interfere with the evaluation of responses or the subject''s successful completion of this trial);
Significant depression (PHQ-9 greater than >9) or generalized anxiety (GAD-7 greater than >9)
Diagnosis of a significant neurological condition such as [...] of an FDA-approved medication for Alzheimer's disease; MoCA less than <23
Diabetes (hbA1c greater than >6.5%) or anti-diabetic medications
History of gastric bypass [...] or [...]
Secondary endpoints2 entries, revised
EvaluateInvestigate the safetyimpact of a six-monththe FMD intervention on cerebral blood flow relative to the Dietary Guidance Group
Investigate the impact of the FMD intervention on cognition relative to normalthe dietDietary Guidance group.
Primary endpoints1 entry, revised
InvestigateEvaluate the impactsafety of thea six-month FMD intervention on cerebral blood flow relative to normal diet
Study description+352 characters
[...] afe (GRAS) selected for their fasting mimicking properties.
The Dietary Guidance Group will receive recommendations based on the Harvard Healthy Eating Plate.
The overarching hypothesis of the study is that theFMD relative to dietary interventionguidance will be safe and well-tolerated.
It is also hypothesized that FMD will be associated with increases in cerebral blood flow. .
This is a phase 2 single-site trial with a randomized, open [...] d to the assigned intervention group.
The study will enroll 6040 participants who will be randomized 1:1 to the fasting-mimicking diet (FMD) intervention versu [...] [...]
Study sitesdetails revised at 1 of 1 site