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mTOR inhibitor

Sirolimus for Brain Health

Phase 1
Recruiting
Led By Ai-Ling Lin, PhD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Carrier Cohort: APOE4 homozygous or heterozygous
Age 45-65 y/o
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at visit 2 immediately before starting sirolimus and visit 4 after 4 weeks of continuous sirolimus
Awards & highlights

Study Summary

This trial will test if a drug can improve blood flow to the brain in people with and without a genetic predisposition to Alzheimer's disease.

Who is the study for?
This trial is for healthy adults aged 45-65 with good cognitive health, as shown by MoCA and CDR scores. It's open to all ethnic groups and includes those genetically predisposed to Alzheimer's (carriers of the APOE4 gene) and those who are not. People with liver or kidney disease, high BMI, diabetes, recent cancer treatments, certain heart conditions, or on medications affecting CYP3A4 can't participate.Check my eligibility
What is being tested?
The study tests whether Sirolimus can improve brain blood flow in individuals at risk for Alzheimer's. Participants will be given Sirolimus and undergo MRI scans to assess changes in cerebral blood flow related to their genetic risk for Alzheimer’s disease.See study design
What are the potential side effects?
Sirolimus may cause side effects like mouth sores, diarrhea, nausea, low blood cell counts increasing infection risk; it might also affect kidneys or lungs and could cause swelling or trouble breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I carry one or two copies of the APOE4 gene.
Select...
I am between 45 and 65 years old.
Select...
My cognitive function is good, with a MoCA score of 26 or higher.
Select...
I do not carry the APOE4 gene.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at visit 2 immediately before starting sirolimus and visit 4 after 4 weeks of continuous sirolimus
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at visit 2 immediately before starting sirolimus and visit 4 after 4 weeks of continuous sirolimus for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Cerebral blood flow as measured on MRI after 4 weeks of Sirolimus

Side effects data

From 2008 Phase 4 trial • 293 Patients • NCT00118742
29%
Diarrhoea
18%
Abdominal Pain
16%
Nausea
16%
Headache
16%
Fatigue
16%
Hepatitis C
14%
Vomiting
14%
Pyrexia
14%
Leukopenia
12%
Oedema Peripheral
11%
Insomnia
10%
Hyperkalaemia
10%
Tremor
10%
Back Pain
10%
Hypertension
10%
Anaemia
9%
Cough
9%
Pruritis
9%
Arthralgia
8%
Neutropenia
8%
Abdominal Pain Upper
8%
Dizziness
8%
Pain in Extremity
8%
Hepatic Enzyme Increased
7%
Dyspnoea
7%
Constipation
7%
Sinusitis
7%
Weight Decreased
6%
Blood Creatinine Increased
6%
Liver Function Test Abnormal
6%
White Blood Cell Count Decreased
5%
Jaundice
5%
Decreased Appetite
5%
Muscle Spasms
5%
Renal Failure
5%
Weight Increased
5%
Upper Respiratory Tract Infection
5%
Nasopharyngitis
5%
Asthenia
5%
Incision Site Pain
5%
Depression
4%
Anorexia
4%
Night Sweats
4%
Oropharyngeal Pain
4%
Rhinorrhoea
3%
Hyperlipidaemia
3%
Pleural Effusion
3%
Thrombocytopenia
3%
Myalgia
3%
Rash
3%
Acne
3%
Incisional Hernia
2%
Hypokalaemia
2%
Pneumonia
2%
Sepsis
1%
Urinary Retention
1%
Spinal Osteoarthritis
1%
Hypercholesterolaemia
1%
Inappropriate Antidiuretic Hormone Secretion
1%
Hypoglycaemia
1%
Blood Glucose Increased
1%
Portal Vein Thrombosis
1%
Cardiac Failure Congestive
1%
Clostridium Difficile Colitis
1%
Abdominal Hernia
1%
Blood Alkaline Phosphatase Increased
1%
Ventricular Tachycardia
1%
Gastrointestinal Tract Adenoma
1%
Encephalopathy
1%
Febrile Neutropenia
1%
Gastritis
1%
Renal Failure Acute
1%
Multi-Organ Failure
1%
Crohn's Disease
1%
Hepatic Neoplasm Malignant
1%
Chest Pain
1%
Non-Small Cell Lung Cancer Metastatic
1%
Transplant Rejection
1%
Benign Prostatic Hyperplasia
1%
Cerebral Haemorrhage
1%
Confusional State
1%
Convulsion
1%
Peritonitis
1%
Haemorrhage Intracranial
1%
Deep Vein Thrombosis
1%
Inguinal Hernia
1%
Viral Infection
1%
Acarodermatitis
1%
Gastrointestinal Haemorrhage
1%
Atrial Fibrillation
1%
Malaise
1%
Hepatic Cancer Metastatic
1%
Adenocarcinoma
1%
B-Cell Lymphoma
1%
Desmoid Tumour
1%
Pulmonary Embolism
1%
Stomatitis
1%
Influenza
1%
Staphylococcal Infection
1%
Umbilical Hernia
1%
Hepatic Function Abnormal
1%
Atrial Flutter
1%
Hyponatraemia
1%
Bacteraemia
1%
Cellulitis
1%
Clostridial Infection
1%
Diverticulitis
1%
Escherichia Urinary Tract Infection
1%
Lactobacillus Infection
1%
Lobar Pneumonia
1%
Pseudomonal Sepsis
1%
Post Procedural Haemorrhage
1%
Procedural Pain
1%
Biliary Anastomosis Complication
1%
Complications of Transplanted Kidney
1%
Bile Duct Obstruction
1%
Bile Duct Stenosis
1%
Biliary Tract Disorder
1%
Autoimmune Hepatitis
1%
Cholestasis
1%
Hepatic Artery Stenosis
1%
Hepatic Failure
1%
Epstein-Barr Virus Associated Lymphoproliferative Disorder
1%
Lung Disorder
1%
Pulmonary Oedema
1%
Sinus Congestion
1%
Embolism Venous
1%
Orthostatic Hypotension
1%
Vasculitis
1%
Hyperglycaemia
1%
Graft Versus Host Disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
CellCept + CNI (Tacrolimus or Cyclosporine)
CellCept + Sirolimus

Trial Design

2Treatment groups
Experimental Treatment
Group I: Non-Carrier APOE4Experimental Treatment1 Intervention
Group II: Carrier APOE4Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
2013
Completed Phase 4
~2750

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
360 Previous Clinical Trials
627,859 Total Patients Enrolled
Ai-Ling Lin, PhDPrincipal InvestigatorUniversity of Missouri-Columbia

Media Library

Sirolimus (mTOR inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05386914 — Phase 1
Genetic Predisposition Research Study Groups: Non-Carrier APOE4, Carrier APOE4
Genetic Predisposition Clinical Trial 2023: Sirolimus Highlights & Side Effects. Trial Name: NCT05386914 — Phase 1
Sirolimus (mTOR inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05386914 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for this trial inclusive of septuagenarians?

"Per the requirements for enrolment in this trial, all participants must be between 45 and 65 years old."

Answered by AI

Is it possible to participate in this scientific experiment?

"This medical trial seeks 105 patients with a genetic susceptibility to disease, falling within the 45 - 65 year old age bracket. Eligible participants must additionally meet the following criteria: 2. Denomination of sex and ethnicity; 4. A 0-rating on their Clinical Dementia Rating Staging Instrument; 5. Being an APOE4 homozygous or heterozygous carrier in case of the Carrier Cohort group; 3. Having Montreal Cognitive Assessment scores greater than 26 points; 6. No identification of APOE4 gene for those enrolled in Non-Carrier cohort group; 1. Age range between 45-65 years old"

Answered by AI

Could you please elucidate the security of Sirolimus for human consumption?

"The safety of Sirolimus was rated a 1 on our scale, due to the limited data collected during Phase I trials which only demonstrate preliminary evidence for its efficacy and safety."

Answered by AI

Is this study actively seeking participants?

"Current information hosted on clinicaltrials.gov displays that this medical trial is inactively searching for participants, with the original posting being 2/1/2023 and last update 10/31/2022. Although this study isn't actively recruiting at present, there are 874 other studies currently enrolling patients."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
Massachusetts
What site did they apply to?
University of Missouri-Columbia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
~21 spots leftby Jul 2024