[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04629495":3,"trial-entities:NCT04629495":125,"trial-summary:NCT04629495":131},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":48,"secondary_outcomes":65,"sex":97,"minimum_age":98,"maximum_age":99,"healthy_volunteers":100,"eligibility_criteria":101,"std_ages":105,"locations":108,"central_contacts":118,"overall_officials":119,"references":123,"see_also_links":124},"NCT04629495","HSC20200763H","Rapamycin - Effects on Alzheimer's and Cognitive Health","Rapamycin - Effects on Alzheimer's and Cognitive Health (REACH)","ACTIVE_NOT_RECRUITING","2027-03-05","2026-06","2026-06-09","2021-08-11","The University of Texas Health Science Center at San Antonio","OTHER",true,"This study will evaluate the safety, tolerability, and feasibility of 12 month oral rapamycin treatment in older adults with amnestic mild cognitive impairment (aMCI) and early stage Alzheimer's disease (AD).","The study will consist of a screening\u002Fbaseline period of up to 90 days pre-study drug, with a 12-month (+3 day) treatment period with rapamycin, followed by a post-treatment assessment completed within 14 days of the final study drug dose, and a final assessment conducted 6-months (+14 days) after the final study drug dose. The study duration is not expected to exceed 90 weeks for participants.",[19,20],"Mild Cognitive Impairment","Alzheimer Disease",[22,23,24],"Cognition","Alzheimer's disease biomarkers","Neuroimaging","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},40,"ACTUAL",[33,41],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","Rapamycin","RAPA will be administered orally 1mg daily",[38],"RAPA (rapamycin) treatment group",[40],"Sirolimus, RAPA",{"type":14,"name":42,"description":43,"armGroupLabels":44,"otherNames":46},"Placebo","Placebo will be administered orally once daily",[45],"Placebo group",[47],"Placebo capsule",[49,53,56,59,62],{"measure":50,"description":51,"timeFrame":52},"Number of adverse events","Development or worsening of medical symptoms or problems","Baseline to 12 months",{"measure":54,"description":55,"timeFrame":52},"Change in glucose level","A comprehensive metabolic panel is used to measure change in glucose level",{"measure":57,"description":58,"timeFrame":52},"Change in albumin","A comprehensive metabolic panel is used to measure change in albumin level",{"measure":60,"description":61,"timeFrame":52},"Change in carbon dioxide or bicarbonate (CO2)","A comprehensive metabolic panel is used to measure change in CO2",{"measure":63,"description":64,"timeFrame":52},"Change in calcium","A comprehensive metabolic panel is used to measure change in calcium levels",[66,70,73,76,79,82,85,88,91,94],{"measure":67,"description":68,"timeFrame":69},"Central nervous system penetration of rapamycin","A lumbar puncture and blood draw will be used to evaluate levels of study drug","Baseline and 12 months",{"measure":71,"description":72,"timeFrame":52},"Change in Cognition using preclinical Alzheimer's Cognitive Composite 5 (PACC5)","Cognition will be measured using the PACC5 scale. The PACC5 is a composite score comprised of measures of global cognition, memory, and executive function. The score reflects an averaged z-score. Scores range from -3 to +3 with higher scores indicating better cognitive performance.",{"measure":74,"description":75,"timeFrame":52},"Change in Cognition using Clinical Dementia Rating Scale sum of Boxes (CDR-SOB)","CDR is obtained through semistructured interviews of patients and informants, and cognitive functioning is rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a 5-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. Domain scores are entered into an online algorithm and CDR-SOB score obtained by summing each of the domain box scores, ranging from 0 to 18. A lower score indicates better cognition.",{"measure":77,"description":78,"timeFrame":52},"Change in Functional status","Functional status will be measured using the functional assessment scale (FAS). The FAS is completed by a collateral source and assesses ability to complete instrumental activities of daily living. The scale has 10-items and responses range from 0-3. The total score is a sum of the individual items. The total score ranges from 0 to 30 with higher scores indicating more assistance needed.",{"measure":80,"description":81,"timeFrame":52},"Change in Neuropsychiatric symptoms","Symptoms will be evaluated using the Geriatric Depression Scale 15 Item (GDS-15). The GDS-15 is a self-report questionnaire with 15 items that have response options of 0 or 1. The total score is the sum of the individual items. The total score on the measure ranges between 0 to 15 with higher scores indicating more depressive symptoms.",{"measure":83,"description":84,"timeFrame":52},"Change in Gait Speed","Gait speed will be evaluated with an electronic gait mat",{"measure":86,"description":87,"timeFrame":52},"Change in Grip Strength","Grip strength will be evaluated with a hand dynamometer",{"measure":89,"description":90,"timeFrame":52},"Change in CSF amyloid beta","Cerebrospinal fluid (CSF) levels of amyloid beta",{"measure":92,"description":93,"timeFrame":52},"Change in cerebral glucose metabolism","Cerebral glucose metabolism is measured using fluorodeoxyglucose-Positron emission tomography (FDG-PET)",{"measure":95,"description":96,"timeFrame":52},"Change in Brain Volumetry","Measure of brain volumetry using MRI","ALL","55 Years","89 Years",false,{"inclusion":102,"exclusion":103,"raw_text":104},[],[],"Inclusion Criteria:\n\n1. Both genders and all ethnic groups\n2. Ages 55 to 89 years\n3. Diagnosis of MCI or AD (Mini Mental Status Examination (MMSE): 18-30; Clinical Dementia Rating Scale (CDR) = 0.5 - 1; California Verbal Learning Test III (CVLT-III) Delayed Recall ≤16% based on age-adjusted norms, clinician approval)\n4. Amyloid positivity based on Amyloid PET Imaging\n5. Labs: Normal blood cell counts without clinically significant excursions; normal liver and renal function; and glucose control (HbA1c \\\u003C 6.5%). Fasting lipid panel and prothrombin time\u002Fprothrombin time test\u002Finternational normalized ration (PT\u002FPTT\u002FINR) within normal limits\n6. A legally authorized representative (LAR) designated to sign informed consent (if necessary) must attend the Screening visit and accompany the participant to all remaining visits to provide reported outcomes\n7. Stable dose of AD medications (Donepezil, rivastigmine, Memantine, galantamine) for at least three months is allowed\n\nExclusion Criteria:\n\n1. Diabetes (HBA1c≥6.5% or antidiabetic medications)\n2. History of skin ulcers or poor wound healing\n3. Current tobacco or illicit drug use or alcohol abuse\n4. Use of anti-platelet or anti-coagulant medications other than aspirin\n5. Current medications that affect cytochrome 450 3A4 (CYP3A4)\n6. Immunosuppressant therapy within the last year\n7. Chemotherapy or radiation treatment within the last year\n8. Current or chronic history of liver or kidney disease or known hepatic or biliary abnormalities\n9. Untreated hypertriglyceridemia (fasting triglycerides \\\u003C 250 mg\u002Fdl)\n10. Current or chronic history of pulmonary disease or abnormal pulse oximetry (\\\u003C90%)\n11. Chronic heart failure\n12. Pregnancy or lactation\n13. Recent history (past six months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack\n14. Significant neurological conditions other than AD or MCI\n15. Poorly controlled blood pressure (systolic BP\\>160, diastolic BP\\>90 mmHg - based on two readings)\n16. Active inflammatory, COVID-19, autoimmune, infectious, hepatic, gastrointestinal, malignant, and\u002For severe mental illness\n17. History of, or MRI, or CT positive for, any space occupying lesion, including mass effect or abnormal intracranial pressure, which would indicate contraindications to lumbar puncture\n18. Organ transplant recipients",[106,107],"ADULT","OLDER_ADULT",[109],{"facility":110,"city":111,"state":112,"zip":113,"country":114,"geoPoint":115},"Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases","San Antonio","Texas","78229","United States",{"lat":116,"lon":117},29.42412,-98.49363,[],[120],{"name":121,"affiliation":13,"role":122},"Sudha J Seshadri, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":126,"biomarkers":129},[127,128],"Alzheimer's Disease","Mild cognitive disorder",[130],"Amyloid",{"nct_id":4,"found":15,"summary":132,"prompt_version":142},{"design":133,"status":134,"heading":135,"summary":136,"follow_up":137,"word_count":138,"commitments":139,"compensation":140,"drugs_mentioned":141},"This is an interventional study, meaning participants will receive either Rapamycin or a placebo. It plans to enroll 40 participants.","completed","Rapamycin for Mild Cognitive Impairment and Alzheimer's Disease","This study is looking at Rapamycin, a drug given by mouth once daily, to see if it's safe and well-tolerated for people with mild cognitive impairment (MCI) or early Alzheimer's disease (AD). You might receive Rapamycin or a placebo (an inactive pill). To join, you need to be between 55 and 89 years old, have a diagnosis of MCI or AD, and have amyloid positivity confirmed by a brain scan (Amyloid PET Imaging). The study will check for any side effects and changes in your glucose (blood sugar) and albumin (a protein in your blood) levels over 12 months. The study is currently recruiting about 40 participants, but its overall status is unclear.","Participants will have a post-treatment assessment within 14 days of the final study drug dose, and a final assessment 6 months after the final study drug dose.",113,"You would have a screening period of up to 90 days, followed by 12 months of daily Rapamycin or placebo. There will be assessments after treatment and a final assessment 6 months later, for a total study duration of up to 90 weeks.","Not stated in the trial record.",[35,42],"v2"]