A Phase 1/2 interventional study of FMD1 (LNT22-017-1) and Rapamycin in Cerebral Blood Flow and APOE 4, sponsored by Cedars-Sinai Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Cedars-Sinai Medical Center · Phase 1/2, Interventional, and Prevention
Among 1,937 studies in Alzheimer Disease with a site in United States — 343 open to participants now, 444 under way, 39 of them phase 3. Alzheimer Disease · United States.
Among the 1,937 studies in Alzheimer Disease with a site in United States, this one is the 863rd largest by planned enrollment of the 1,606 interventional ones, is one of 89 that started in 2026, is one of 67 in phase 1/2, reaches primary completion later than 288 of the 443 other live ones, and was the 1,753rd registered.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →343 of the 1,937 studies in Alzheimer Disease with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 641 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 54 (8%) stop at 75 or younger; 34 take children under 18; 283 take healthy volunteers.
This study: 45 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →1,937 studies; the count open now beside each. This study's row is marked.
First in 1981; this study’s year is marked. 89 started in 2026.
Median enrollment 73 across the 1,606 interventional studies, 160 across the 309 observational. Of the 1,376 that completed or were terminated, 590 (43%) have results posted.
730 of 1,937 have an industry lead sponsor. The 10 most frequent:
Cedars-Sinai Medical Center is the lead sponsor of 456 studies on the registry; 107 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.
Cedars-Sinai Medical Center has 4 studies filed under Alzheimer Disease — fewer than ten, so there is no comparison to draw.
165 of the studies in Alzheimer Disease with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
| NCT06126224Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) | 2026-12-09 |
| NCT03860857Phase 3University of California, IrvineBiomarker Exploration in Aging, Cognition and Neurodegeneration | 2026-12-22 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT05980949Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyOpen-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) | 2027-09-07 |
Among the 1,937 studies in Alzheimer Disease with a site in United States, from their registry updates:
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.
Participants assigned to the FMD arm will adhere to the diet for 5 days over three cycles for a period of 8 weeks. The FMD diet is produced by L-Nutra and provides 1100 kcals on day 1 and 800 kcals on days 2-5. The diet consists of ingredients which are Generally Regarded As Safe (GRAS) selected for their fasting mimicking properties. Participants randomized to the rapamycin group will receive 1 mg rapamycin daily for 8 weeks and those in the placebo arm will take one matched placebo pill daily for 8 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the FMD group will be asked to refrain from consuming any calorie-containing foods or drinks other than the provided study foods/drinks during the designated intervention days each month.
Dietary Supplement: FMD1 (LNT22-017-1)
Participants randomly assigned to the rapamycin arm will take 1 mg of rapamycin daily for approximately 8 weeks.
Drug: Rapamycin
Participants randomly assigned to the placebo arm will take one placebo pill daily for approximately 8 weeks.
Drug: Placebo
FMD is a plant-based ketogenic diet that provides essential nutrients while maintaining hypo-caloric content. FMD is administered cyclically with 3-5 consecutive days of the diet followed by resumption of normal eating.
Participants randomly assigned to the rapamycin arm will take 1 mg of rapamycin daily for approximately 8 weeks..
Participants randomly assigned to the placebo arm will take one placebo pill daily for approximately 8 weeks.
Evaluate and compare the safety of an approximately 8-week FMD or low dose rapamycin intervention relative to a matched control group
Endpoint: Number of adverse events in the intervention groups relative to the placebo group.
Time frame: From pre- to post-treatment (Day 72 +/- 5 days)
Investigate the effect of an approximately 8-week FMD or low dose rapamycin intervention relative to a matched control group.
Endpoint: Cerebral blood flow - Cerebral blood flow will be assessed through brain magnetic resonance imaging arterial spin labeling sequence.
Time frame: From pre- to post-treatment (Day 72 +/- 5 days)
Investigate and compare the impact of the FMD and rapamycin interventions on cognition relative to the placebo group.
NIH Toolbox Flanker and Pattern Comparison Tests and the Mayo Preclinical Alzheimer's Cognitive Composite. The NIH Toolbox assessments are measured through scaled scores (T-scores), which range from 20-80 with higher scores indicating better outcomes. The Mayo Preclinical Alzheimer's Cognitive Composite is also measured using a standardized score (Z-score) with mean of 0 and a standard deviation of 1. Higher scores indicate better performance.
Time frame: From pre- to post-treatment (Day 72 +/- 5 days)
Examine and compare impact of FMD and rapamycin relative to placebo on ADRD blood-based biomarkers
Endpoint: Circulating levels of phosphorylated tau 217 (p-tau 217), neurofilament light (NFL), and glial fibrillary acidic protein (GFAP). The same unit of measurement applies for all - pg/ml.
Time frame: From pre- to post-treatment (Day 72 +/- 5 days)
Evaluate and compare the efficacy of FMD and rapamycin relative to placebo for modulating autophagic flux
Endpoint: Autophagic flux in PBMCs and tissue (optional) Autophagy related gene expression. Both have the same unit of measurement as arbitrary units.
Time frame: From pre- to post-treatment (Day 72 +/- 5 days)
Evaluate and compare the efficacy of FMD and rapamycin relative to placebo for modulating insulin growth factor-1
Endpoint: insulin growth factor 1 (unit of measure is ng/ml)
Time frame: From pre- to post-treatment (Day 72 +/- 5 days)
Examine and compare the impact of FMD and rapamycin relative to placebo on systemic markers of inflammation through physiological parameters.
Endpoint: Proteomic expression of pro-inflammatory markers Pro-inflammatory markers are IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, which are all measured in pg/ml.
Time frame: From pre- to post-treatment (Day 72 +/- 5 days)
Evaluate and compare the efficacy of FMD and rapamycin relative to placebo on epigenetic clock
Endpoint: Epigenetic modifications in peripheral blood mononuclear cells (unit of measure is DNA methylation age acceleration)
Time frame: From enrollment to end of study (Day 72 +/- 5 days)
Evaluate and compare the efficacy of FMD and rapamycin relative to placebo for fasting blood glucose levels
Endpoint: blood glucose (mg/dl)
Time frame: From pre- to post-treatment (Day 72 +/- 5 days)
Evaluate the efficacy of FMD and rapamycin relative to Dietary Guidance for body composition
Endpoint: percent body fat and muscle mass (measure of unit: %)
Time frame: From pre- to post-treatment (Day 72 +/- 5 days)
Evaluate and compare the impact of FMD and rapamycin relative to placebo on physical functioning.
Endpoint: Gait speed (meters/second)
Time frame: From pre- to post-treatment (Day 72 +/- 5 days)
Plan to share: Yes — Data collected for this study will be analyzed and stored at Cedars Sinai. After the study is completed, the de-identified, archived data will be stored at Cedars Sinai for use by other researchers including those outside of the study. As new relevant methodologies are developed, however, there is a conceivable future interest to process deidentified samples and data in a collaborating laboratory at Cedars-Sinai Medical Center or outside of Cedars-Sinai Medical Center including commercial entities. Participants are made aware of this possibility in the written informed consent form at the time of enrollment and are informed that to consent to this study is also to consent to permit coded data to be shared for the purposes of this research. The key to the code is not shared with collaborators but will remain in a HIPAA-compliant, secure, REDCap database at Cedars-Sinai Medical Center.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: De-identified data will be available within 6 months of release of the primary endpoint results and will be made available by request indefinitely
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA)
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2028, 16 months later.
Of 35 non-industry phase 1/2 interventional studies under Alzheimer Disease, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 63. This study's planned 16 months is below that.
Counting every sponsor, half of 62 studies reached it within 45 months; a quarter within 21 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sirolimus