Cognitive Impairment, MildEarly Phase 1CARPE_DIEMNCT04200911
Cognition, Age, and RaPamycin Effectiveness - DownregulatIon of thE mTor Pathway
A Early Phase 1 study testing Rapamune in people with Cognitive Impairment, Mild and Alzheimer Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Evaluation of central nervous system penetration of orally administered Rapamune (RAPA) in older adults with Mild Cognitive Impairment (MCI) or early Alzheimer's disease (AD) and investigate associated safety, tolerability, target engagement, cognition, and functional status as initial proof-of-concept study Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Mild, Alzheimer Disease
- What is being tested?
- Rapamune
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 13 Jan 2022
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's disease, Global Clinical Dementia Rating Scale (CDR)=0.5-1
- Normal blood cell counts without clinically significant excursions; ; normal liver and renal function; and glucose control (HbA1c < 6.5%). Lipid panel and PT/PTT/INR within normal limits
- A Legally Authorized Representative (LAR) if necessary for consent
- An LAR or study partner to accompany participant to all visits
- Availability for all study visits
- Stable dose of AD medications) Donepezil, rivastigmine, memantine, galantamine) for at least 3 months prior to the baseline visit
Who cannot join
- Diabetes (HbA1c≥6.5% or anti-diabetic medications)
- History of skin ulcers or poor wound healing
- Current tobacco or illicit drug use or alcohol abuse
- Use of anti-platelet or anti-coagulant medications other than aspirin
- Current medications that affect cytochrome P450 3A4; current or recent medications for hypertriglyceridemia (eg, Gemfibrozil)
- Hypersensitivity or history of allergy to Rapamycin
Show all 19Show fewer
- Immunosuppressant therapy within the last year; current treatment with hydroxychloroquine and chloroquine (requires "washout period" of 14 days)
- Chemotherapy or radiation treatment within the last year
- Current or chronic history of liver disease or known hepatic or biliary abnormalities
- History of primary hypertriglyceridemia. Abnormal triglycerides >200 or LDL cholesterol >193, or other abnormal labs deemed clinically significant upon investigator review
- Current or chronic history of pulmonary disease or abnormal pulse oximetry (<90%)
- Chronic heart failure
- Pregnancy
- Recent history (past 6 months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack
- significant neurological conditions other than AD
- Poorly controlled blood pressure (systolic BP>160, diastolic BP>90mmHg)
- Active inflammatory, COVID-19, autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or psychiatric disease
- History of, or Magnetic Resonance Imaging (MRI) positive for any space occupying lesion, including mass effect and/or abnormal intracranial pressure, which would indicate contraindication to lumbar puncture
- Organ transplant recipients
Trial locations and contacts
1 site in 1 country.
United States1 site
UTHSA McDermott Clinical Sciences Building
San Antonio, Texas, 78229
About this study
Official title: Cognition, Age, and RaPamycin Effectiveness - DownregulatIon of thE mTor Pathway (CARPE DIEM)
Evaluation of central nervous system penetration of orally administered Rapamune (RAPA) in older adults with Mild Cognitive Impairment (MCI) or early Alzheimer's disease (AD) and investigate associated safety, tolerability, target engagement, cognition, and functional status as initial proof-of-concept study
Read the detailed description
This study is an open-label pilot study of orally administered RAPA to measure its target engagement in Cerebrospinal Fluid (CSF) and blood, and to establish the feasibility and safety of RAPA treatment in older adults with MCI and early stage AD as initial proof-of-concept for a larger Phase 2 clinical trial.
- Conditions
- Cognitive Impairment, Mild, Alzheimer Disease
- Being tested
- Rapamune
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamuneDrug
Also called Sirolimus
Sirolimus 1mg capsules
| Study group | Role | What they receive |
|---|---|---|
| RAPA intervention | Experimental | Sirolimus 1mg orally once a day for 8 weeks Receives: Drug: Rapamune |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Brain Barrier Penetration of RAPA
Lumbar punctures will be performed at baseline and after the final RAPA dose, to assess CSF levels of the drug. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: Change from Baseline to 8 weeks
Secondary outcomes (41)
Adverse Events
Number of adverse events experienced across all 10 subjects after they were enrolled and randomized to treatment, regardless of relatedness to intervention.
Measured: Baseline to 8 weeks
Change in Vitals From Baseline to 8 Weeks
Evaluation of vitals. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: Baseline to 8 weeks
Percentage of Study Drug Pills Taken
Average percentage of study drug pills taken across all 10 subjects after they were enrolled and randomized to treatment. The percentage of study drug pills taken was evaluated by having participants return any leftover study drug pills at each visit during the active treatment period.
Measured: Baseline to 8 weeks
Change in CSF AD Biomarkers From Baseline to 8 Weeks
Evaluation of CSF AD biomarkers. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: Baseline to 8 weeks
Change in Plasma AD Biomarkers From Baseline to 8 Weeks
Evaluation of plasma AD biomarkers. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: Baseline to 8 weeks
Change in CSF Inflammatory Markers From Baseline to 8 Weeks
Evaluation of CSF inflammatory markers. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: Baseline to 8 weeks
Change in Plasma Inflammatory Markers From Baseline to 8 Weeks
Evaluation of plasma inflammatory markers. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: Baseline to 8 weeks
Safety Labs - Change in White Blood Cell and Platelet Counts From Baseline to 8 Weeks
Evaluation of safety labs - white blood cell and platelet counts. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: Baseline to 8 weeks
Safety Labs - Change in Red Blood Cell Count
Evaluation of safety labs - red blood cell counts. Change in red blood cell count calculated as value at 8 weeks minus the value at baseline.
Measured: Baseline to 8 weeks
Safety Labs - Change in Mean Corpuscular Volume
Evaluation of safety labs - Change in Mean Corpuscular volume. Change is calculated as value at 8 weeks minus the value at baseline
Measured: 8 weeks
Safety Labs - Change in Mean Corpuscular Hemoglobin
safety labs - Mean Corpuscular Hemoglobin. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8-weeks
Safety Labs - Change in Metabolic Parameters (g/dl)
Evaluation of safety labs - metabolic parameters. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Safety Labs - Change in Hematocrit
Evaluation of of safety labs - hematocrit. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Safety Labs - Change in Monocytes
Evaluation of of safety labs - monocytes. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Safety Labs - Change in Red Cell Distribution Width
Evaluation of of safety labs - Red cell distribution width. Change is calculated as value at 8 weeks minus the value at baseline. The value reported is % of red blood cell size and volume variability.
Measured: 8 weeks
Safety Labs - Change in Hemoglobin A1c
Evaluation of of safety labs - hemoglobin A1c. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl)
Evaluation of safety labs - metabolic and lipid parameters. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Safety Labs - Change in Sodium and Potassium (mmol/L)
Evaluation of safety labs - sodium and potassium. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Safety Labs - Change in Liver Panel (iU/L)
Evaluation of safety labs - liver panel. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change in Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) assesses global cognition with scores ranging from 0 to 30 points. Higher scores indicate better performance.Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Clinical Rating Scale Global Score
The Clinical Rating Scale Global Score assesses cognition and daily functioning with scores ranging from 0 to 3 points. Higher scores indicate worse cognition and/or functional status.Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Clinical Rating Scale Sum of Boxes Score
The Clinical Rating Scale Sum of Boxes assesses cognition and daily functioning with scores ranging from 0 to 18 points. Higher scores indicate worse cognition and/or functional status.Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Immediate Recall
The Hopkins Verbal Learning Test - Revised Immediate Recall assesses verbal list learning with scores ranging from 0 to 36 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Delayed Recall
The Hopkins Verbal Learning Test - Revised Delayed Recall assesses verbal list learning with scores ranging from 0 to 12 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Craft Story Immediate Recall Verbatim
The Craft Story Immediate Recall Verbatim assesses verbal narrative learning with scores ranging from 0 to 44 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Craft Story Delayed Recall Verbatim
The Craft Story Delayed Recall Verbatim assesses verbal memory recall with scores ranging from 0 to 44 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Benson Figure Copy
The Benson Figure Copy assesses visuoconstructional skills with scores ranging from 0 to 17points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Benson Figure Delayed Recall
The Benson Figure Delayed Recall assesses visual memory with scores ranging from 0 to 17 points. Higher scores indicate better performance.Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Number Span Forward
The Number Span Forward test assesses basic attention with scores ranging from 0 to 16 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Number Span Backward
The Number Span Backward test assesses working memory with scores ranging from 0 to 14 points. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Trail Making Test Part A, Time to Completion
The Trail Making Test Part A, time to completion assesses psychomotor speed and visual scanning with scores ranging from 1 to 150 seconds. Higher scores indicate worse performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change Trail Making Test Part B, Time to Completion
The Trail Making Test Part B, time to completion assesses attentional shifting with scores ranging from 1 to 300 seconds. Higher scores indicate worse performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on Phonemic Fluency
The Phonemic fluency test assesses speeded word generation to a phonemic cue. Scores begin at 0 with no upper limit. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on Semantic Fluency
The Semantic fluency test assesses speeded word generation to a semantic cue. Scores begin at 0 with no upper limit. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Multilingual Naming Test
The Multilingual Naming Test assesses confrontation naming. Scores range from 0 to 32 and higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Hayling, Total Errors
The Hayling assesses response inhibition errors. Scores range from 0 to 30 and higher scores indicate worse performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on Grip Strength, Dominant Hand
The grip strength, dominant hand assesses grip strength in kilograms. Values begin at 0 with no upper limit. Higher scores indicate better performance Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on Grip Strength, Non-dominant Hand
The grip strength, non-dominant hand assesses grip strength in kilograms. Values begin at 0 with no upper limit. Higher scores indicate better performance. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Geriatric Depression Scale 15-item
The Geriatric Depression Scale 15-item assesses depressive symptomatology. Scores range from 0 to 15 and higher scores indicate worse outcomes. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Functional Activities Questionnaire
The Functional Activities Questionnaire assesses functional status for independent activities of daily living. Scores range from 0 to 30 and higher scores indicate worse outcomes. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Cognition/Functional Status - Change on the Neuropsychiatric Inventory Questionnaire
The Neuropsychiatric Inventory Questionnaire assesses neuropsychiatric symptoms. Scores range from 0 to 12 and higher scores indicate worse outcomes. Change is calculated as value at 8 weeks minus the value at baseline.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start1 Jun 2020
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive Impairment, MildStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Mitzi Gonzales, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200911
- Sponsor's protocol ID
- HSC20190850H
- Other IDs
- UL1TR002645
- Acronym
- CARPE_DIEM
- Status last verified
- Jan 2025
- First submitted
- 6 Dec 2019
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Institution, Sponsor or respective designees may review results prior to presenting or publishing the results of a scientific investigation involving this Study in accordance with ICJME guidelines and institutional requirements.
Publications
Gonzales MM, Garbarino VR, Kautz TF, Song X, Lopez-Cruzan M, Linehan L, Van Skike CE, De Erausquin GA, Galvan V, Orr ME, Musi N, He Y, Bateman RJ, Wang CP, Seshadri S, Kraig E, Kellogg D Jr. Rapamycin treatment for Alzheimer's disease and related dementias: a pilot phase 1 clinical trial. Commun Med (Lond). 2025 May 20;5(1):189. doi: 10.1038/s43856-025-00904-9.
PubMed 40394335
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition, Age, and RaPamycin Effectiveness - DownregulatIon of thE mTor Pathway (CARPE DIEM)
- ClinicalTrials.gov ID
- NCT04200911
- Acronym / sponsor ID
- CARPE_DIEM / HSC20190850H
- Conditions
- Cognitive Impairment, Mild, Alzheimer Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Posted 21 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of central nervous system penetration of orally administered Rapamune (RAPA) in older adults with Mild Cognitive Impairment (MCI) or early Alzheimer's disease (AD) and investigate associated safety, tolerability, target engagement, cognition, and functional status as initial proof-of-concept study
Detailed description
This study is an open-label pilot study of orally administered RAPA to measure its target engagement in Cerebrospinal Fluid (CSF) and blood, and to establish the feasibility and safety of RAPA treatment in older adults with MCI and early stage AD as initial proof-of-concept for a larger Phase 2 clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAPA intervention | Experimental | Drug: RapamuneSirolimus 1mg orally once a day for 8 weeks |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's disease, Global Clinical Dementia Rating Scale (CDR)=0.5-1
- Normal blood cell counts without clinically significant excursions; ; normal liver and renal function; and glucose control (HbA1c < 6.5%). Lipid panel and PT/PTT/INR within normal limits
- A Legally Authorized Representative (LAR) if necessary for consent
- An LAR or study partner to accompany participant to all visits
- Availability for all study visits
Key exclusion criteria (19 listed)
- Diabetes (HbA1c≥6.5% or anti-diabetic medications)
- History of skin ulcers or poor wound healing
- Current tobacco or illicit drug use or alcohol abuse
- Use of anti-platelet or anti-coagulant medications other than aspirin
- Current medications that affect cytochrome P450 3A4; current or recent medications for hypertriglyceridemia (eg, Gemfibrozil)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RapamuneAlso: SirolimusSirolimus 1mg capsules | Drug | RAPA intervention |
Primary outcome
Blood Brain Barrier Penetration of RAPA
Time frame: Change from Baseline to 8 weeks
Lumbar punctures will be performed at baseline and after the final RAPA dose, to assess CSF levels of the drug. Change is calculated as value at 8 weeks minus the value at baseline.
41 secondary outcomes
Adverse Events
Time frame: Baseline to 8 weeks
Change in Vitals From Baseline to 8 Weeks
Time frame: Baseline to 8 weeks
Percentage of Study Drug Pills Taken
Time frame: Baseline to 8 weeks
Change in CSF AD Biomarkers From Baseline to 8 Weeks
Time frame: Baseline to 8 weeks
Change in Plasma AD Biomarkers From Baseline to 8 Weeks
Time frame: Baseline to 8 weeks
Change in CSF Inflammatory Markers From Baseline to 8 Weeks
Time frame: Baseline to 8 weeks
Change in Plasma Inflammatory Markers From Baseline to 8 Weeks
Time frame: Baseline to 8 weeks
Safety Labs - Change in White Blood Cell and Platelet Counts From Baseline to 8 Weeks
Time frame: Baseline to 8 weeks
Safety Labs - Change in Red Blood Cell Count
Time frame: Baseline to 8 weeks
Safety Labs - Change in Mean Corpuscular Volume
Time frame: 8 weeks
Safety Labs - Change in Mean Corpuscular Hemoglobin
Time frame: 8-weeks
Safety Labs - Change in Metabolic Parameters (g/dl)
Time frame: 8 weeks
Safety Labs - Change in Hematocrit
Time frame: 8 weeks
Safety Labs - Change in Monocytes
Time frame: 8 weeks
Safety Labs - Change in Red Cell Distribution Width
Time frame: 8 weeks
Safety Labs - Change in Hemoglobin A1c
Time frame: 8 weeks
Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl)
Time frame: 8 weeks
Safety Labs - Change in Sodium and Potassium (mmol/L)
Time frame: 8 weeks
Safety Labs - Change in Liver Panel (iU/L)
Time frame: 8 weeks
Cognition/Functional Status - Change in Montreal Cognitive Assessment (MoCA)
Time frame: 8 weeks
Cognition/Functional Status - Change on the Clinical Rating Scale Global Score
Time frame: 8 weeks
Cognition/Functional Status - Change on the Clinical Rating Scale Sum of Boxes Score
Time frame: 8 weeks
Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Immediate Recall
Time frame: 8 weeks
Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Delayed Recall
Time frame: 8 weeks
Cognition/Functional Status - Change on the Craft Story Immediate Recall Verbatim
Time frame: 8 weeks
Cognition/Functional Status - Change on the Craft Story Delayed Recall Verbatim
Time frame: 8 weeks
Cognition/Functional Status - Change on the Benson Figure Copy
Time frame: 8 weeks
Cognition/Functional Status - Change on the Benson Figure Delayed Recall
Time frame: 8 weeks
Cognition/Functional Status - Change on the Number Span Forward
Time frame: 8 weeks
Cognition/Functional Status - Change on the Number Span Backward
Time frame: 8 weeks
Cognition/Functional Status - Change on the Trail Making Test Part A, Time to Completion
Time frame: 8 weeks
Cognition/Functional Status - Change Trail Making Test Part B, Time to Completion
Time frame: 8 weeks
Cognition/Functional Status - Change on Phonemic Fluency
Time frame: 8 weeks
Cognition/Functional Status - Change on Semantic Fluency
Time frame: 8 weeks
Cognition/Functional Status - Change on the Multilingual Naming Test
Time frame: 8 weeks
Cognition/Functional Status - Change on the Hayling, Total Errors
Time frame: 8 weeks
Cognition/Functional Status - Change on Grip Strength, Dominant Hand
Time frame: 8 weeks
Cognition/Functional Status - Change on Grip Strength, Non-dominant Hand
Time frame: 8 weeks
Cognition/Functional Status - Change on the Geriatric Depression Scale 15-item
Time frame: 8 weeks
Cognition/Functional Status - Change on the Functional Activities Questionnaire
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40394335Gonzales MM, Garbarino VR, Kautz TF, Song X, Lopez-Cruzan M, Linehan L, Van Skike CE, De Erausquin GA, Galvan V, Orr ME, Musi N, He Y, Bateman RJ, Wang CP, Seshadri S, Kraig E, Kellogg D Jr. Rapamycin treatment for Alzheimer's disease and related dementias: a pilot phase 1 clinical trial. Commun Med (Lond). 2025 May 20;5(1):189. doi: 10.1038/s43856-025-00904-9.
- Individual participant dataSharing planned: Yes. The Institution, Sponsor or respective designees may review results prior to presenting or publishing the results of a scientific investigation involving this Study in accordance with ICJME guidelines and institutional requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitzi Gonzales, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rapamune in people with Cognitive Impairment, Mild and Alzheimer Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Brain Barrier Penetration of RAPA (time frame: Change from Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04200911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.