{"type":"trials","record":{"id":5245,"source_id":"clinicaltrials-gov","external_id":"NCT06682767","title":"A Nutritional and Pharmacological Intervention for Body, Brain, and Longevity Effects (NIBBLE)","brief_summary":"The study aims to evaluate the safety, feasibility, and preliminary efficacy of the fasting-mimicking diet (FMD) or low-dose daily rapamycin treatment relative to a matched placebo control group when administered over 8 weeks in middle-aged adults at elevated risk for Alzheimer's disease due to the apolipoprotein (APOE) ε4 allele. Participants randomly assigned to the FMD intervention will adhere to FMD for 5-days over three cycles for a period of approximately 8 weeks. Participants randomly assigned to the rapamycin and placebo groups will take 1 mg of rapamycin or a matched placebo pill daily for approximately 8 weeks.","overall_status":"Not Yet Recruiting","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Cedars-Sinai Medical Center","enrollment":60,"countries":["United States"],"start_date":"2026-11-01","completion_date":"2028-06-01","last_update_date":"2026-09-16","source_url":"https://clinicaltrials.gov/study/NCT06682767","editorial_summary":"A registered PHASE1, PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-16T12:17:03.135426+00:00","last_seen_at":"2026-09-25T06:05:56.331+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"45 Years to 65 Years","comparator":"Placebo","organization":"Cedars-Sinai Medical Center","interventions":["FMD1 (LNT22-017-1)","Rapamycin","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Evaluate and compare the safety of an approximately 8-week FMD or low dose rapamycin intervention relative to a matched…","Investigate the effect of an approximately 8-week FMD or low dose rapamycin intervention relative to a matched control…","Investigate and compare the impact of the FMD and rapamycin interventions on cognition relative to the placebo group. —…"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · QUADRUPLE","source_has_results":false},"controlled_terms":["Cerebral Blood Flow","APOE 4","FMD1 (LNT22-017-1)","Rapamycin","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Abstract contains controlled term: rapamycin.","quality_checked_at":"2026-09-25T06:05:58.178511+00:00","duplicate_cluster_key":"id:nct06682767","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-11-01 to 2028-06-01","comparator":"Placebo","confidence":"structured-source","population":"ALL · 45 Years to 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:05:56.332Z","intervention":["FMD1 (LNT22-017-1)","Rapamycin","Placebo"],"participants":60,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1, PHASE2","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Evaluate and compare the safety of an approximately 8-week FMD or low dose rapamycin intervention relative to a matched…","Investigate the effect of an approximately 8-week FMD or low dose rapamycin intervention relative to a matched control…","Investigate and compare the impact of the FMD and rapamycin interventions on cognition relative to the placebo group. —…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"rapamycin","is_published":true,"match_reasons":["Abstract contains controlled term: rapamycin.","Source terminology contains: rapamycin.","Title supplies longevity context: longevity.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Rapamycin","slug":"rapamycin"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/5245","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}