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CARPE_DIEM

CompletedPhase EARLY_1Results posted

Cognition, Age, and RaPamycin Effectiveness - DownregulatIon of thE mTor Pathway

Cognition, Age, and RaPamycin Effectiveness - DownregulatIon of thE mTor Pathway (CARPE DIEM)

Asset

Sirolimus

Listed sites

1

Recruiting sites

-

Enrollment

10

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•AD symptomatic therapy: stable ≥3 months

Primary endpoint

•Blood Brain Barrier Penetration of RAPA

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDHSC20190850H
NCT IDNCT04200911
NihUL1TR002645

Timeline

Milestones

Study first posted2019-12-16actual
Study start2020-06-01actual
Primary completion2022-01-13actual
Study completion2022-01-13actual
Results first posted2023-03-21actual
Last update posted2025-01-08actual

Assets

Drug assets

Sirolimus

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•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

Exclusion criteria

•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
•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

Endpoints (84)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
26
Other (unclassified)
18
Memory
12
Executive function / language
10
Fluid / digital biomarkers
6
Behavior / neuropsychiatric
4
Other clinical outcomes
4
Global cognition
2
Function / daily living
2

Global cognition

2 endpoints
Secondary/protocol endpoint

Cognition/Functional Status - Change in Montreal Cognitive Assessment (MoCA)

Time frame:8 weeks

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Secondary/registry result

Cognition/Functional Status - Change in Montreal Cognitive Assessment (MoCA)

Time frame:8 weeks

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants-1.302.45

Memory

12 endpoints
Secondary/protocol endpoint

Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Immediate Recall

Time frame:8 weeks

categorical status, descriptive

Secondary/protocol endpoint

Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Delayed Recall

Time frame:8 weeks

categorical status, descriptive

Secondary/protocol endpoint

Cognition/Functional Status - Change on the Craft Story Immediate Recall Verbatim

Time frame:8 weeks

categorical status, descriptive

Secondary/protocol endpoint

Cognition/Functional Status - Change on the Craft Story Delayed Recall Verbatim

Time frame:8 weeks

categorical status, descriptive

Secondary/protocol endpoint

Cognition/Functional Status - Change on the Benson Figure Delayed Recall

Time frame:8 weeks

categorical status, descriptive

Secondary/protocol endpoint

Cognition/Functional Status - Change on the Number Span Backward

Time frame:8 weeks

categorical status, descriptive

Secondary/registry result

Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Immediate Recall

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants0.403.37
Secondary/registry result

Cognition/Functional Status - Change on the Hopkins Verbal Learning Test - Revised Delayed Recall

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants-1.002.54
Secondary/registry result

Cognition/Functional Status - Change on the Craft Story Immediate Recall Verbatim

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants0.204.29
Secondary/registry result

Cognition/Functional Status - Change on the Craft Story Delayed Recall Verbatim

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants-1.402.95
Secondary/registry result

Cognition/Functional Status - Change on the Benson Figure Delayed Recall

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants-0.802.04
Secondary/registry result

Cognition/Functional Status - Change on the Number Span Backward

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants-0.600.84

Executive function / language

10 endpoints
Secondary/protocol endpoint

Cognition/Functional Status - Change on the Number Span Forward

Time frame:8 weeks

categorical status, descriptive

Secondary/protocol endpoint

Cognition/Functional Status - Change on the Trail Making Test Part A, Time to Completion

Time frame:8 weeks

time to event, event

Secondary/protocol endpoint

Cognition/Functional Status - Change Trail Making Test Part B, Time to Completion

Time frame:8 weeks

time to event, event

Secondary/protocol endpoint

Cognition/Functional Status - Change on Semantic Fluency

Time frame:8 weeks

ratio, descriptive

Secondary/protocol endpoint

Cognition/Functional Status - Change on the Multilingual Naming Test

Time frame:8 weeks

categorical status, descriptive

Secondary/registry result

Cognition/Functional Status - Change on the Number Span Forward

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants0.201.62
Secondary/registry result

Cognition/Functional Status - Change on the Trail Making Test Part A, Time to Completion

Time frame:8 weeks

time to event, event

Posted result

GroupValue (mean), seconds to completeStandard deviation
RAPA Interventionn=10 Participants3.093.15
Secondary/registry result

Cognition/Functional Status - Change Trail Making Test Part B, Time to Completion

Time frame:8 weeks

time to event, event

Posted result

GroupValue (mean), seconds to completeStandard deviation
RAPA Interventionn=10 Participants26.6914.97
Secondary/registry result

Cognition/Functional Status - Change on Semantic Fluency

Time frame:8 weeks

ratio, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants1.104.18
Secondary/registry result

Cognition/Functional Status - Change on the Multilingual Naming Test

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants1.504.67

Function / daily living

2 endpoints
Secondary/protocol endpoint

Cognition/Functional Status - Change on the Functional Activities Questionnaire

Time frame:8 weeks

categorical status, descriptive

Secondary/registry result

Cognition/Functional Status - Change on the Functional Activities Questionnaire

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants-0.104.36

Behavior / neuropsychiatric

4 endpoints
Secondary/protocol endpoint

Cognition/Functional Status - Change on the Geriatric Depression Scale 15-item

Time frame:8 weeks

categorical status, descriptive

Secondary/protocol endpoint

Cognition/Functional Status - Change on the Neuropsychiatric Inventory Questionnaire

Time frame:8 weeks

Neuropsychiatric Inventory (NPI)

categorical status, descriptive

Secondary/registry result

Cognition/Functional Status - Change on the Geriatric Depression Scale 15-item

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants0.101.73
Secondary/registry result

Cognition/Functional Status - Change on the Neuropsychiatric Inventory Questionnaire

Time frame:8 weeks

Neuropsychiatric Inventory (NPI)

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants0.702.83

Fluid / digital biomarkers

6 endpoints
Primary/protocol endpoint

Blood Brain Barrier Penetration of RAPA

Time frame:Change from Baseline to 8 weeks

ratio, descriptive

Primary/registry result

Blood Brain Barrier Penetration of RAPA

Time frame:Change from Baseline to 8 weeks

ratio, descriptive

Posted result

GroupValue (mean), ng/mlStandard deviation
RAPA Interventionn=10 Participants00
Secondary/protocol endpoint

Change in CSF AD Biomarkers From Baseline to 8 Weeks

Time frame:Baseline to 8 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in CSF Inflammatory Markers From Baseline to 8 Weeks

Time frame:Baseline to 8 weeks

change from baseline, improvement

Secondary/registry result

Change in CSF AD Biomarkers From Baseline to 8 Weeks

Time frame:Baseline to 8 weeks

change from baseline, improvement

Posted result

GroupValue (mean), ng/mlStandard deviation
RAPA InterventionCSF ptau-181n=10 Participants2.642.72
CSF abeta 40n=10 Participants615.571210.06
CSF Abeta42n=10 Participants21.5262.12
CSF GFAPn=10 Participants6262.214928.96
CSF NFLn=10 Participants367.18310.71
Secondary/registry result

Change in CSF Inflammatory Markers From Baseline to 8 Weeks

Time frame:Baseline to 8 weeks

change from baseline, improvement

Posted result

GroupValue (mean), pg/mlStandard deviation
RAPA InterventionIL-10n=10 Participants0.020.02
IL-6n=10 Participants-0.020.25
IL-8n=10 Participants5.769.10
TNF-αn=10 Participants0.030.07
IL-12n=10 Participants0.350.53
IL-15n=10 Participants0.290.28
IL-16n=10 Participants0.633.40
IL-17an=10 Participants0.030.09
IL-1an=10 Participants-0.150.33
IL-5n=10 Participants0.070.07
IL-7n=10 Participants0.0040.10
VEGF-An=10 Participants0.952.37
VEGF-Cn=10 Participants266.60575.93
VEGF-Dn=10 Participants109.64117.23
Eotaxinn=10 Participants-5.0532.40
Eotaxin-3n=10 Participants-0.202.20
IP-10n=10 Participants-12.93143.87
MCP-1n=10 Participants-22.5678.00
MIP1-αn=10 Participants0.832.90
sFLT-1n=10 Participants41.18253.61
PIGFn=10 Participants2.8440.66
bFGFn=10 Participants-0.6920.85
sVCAM1n=10 Participants21202.5724439.62
sICAM1n=10 Participants6701.2113402.98
SAAn=10 Participants-73762.91375497.74
CRPn=10 Participants-98910.4527540.81
IFN-γn=10 Participants0.140.17

Safety / tolerability / PK

26 endpoints
Secondary/protocol endpoint

Adverse Events

Time frame:Baseline to 8 weeks

event count, event

Secondary/protocol endpoint

Safety Labs - Change in White Blood Cell and Platelet Counts From Baseline to 8 Weeks

Time frame:Baseline to 8 weeks

change from baseline, event

Secondary/protocol endpoint

Safety Labs - Change in Red Blood Cell Count

Time frame:Baseline to 8 weeks

change from baseline, event

Secondary/protocol endpoint

Safety Labs - Change in Mean Corpuscular Volume

Time frame:8 weeks

change from baseline, event

Secondary/protocol endpoint

Safety Labs - Change in Mean Corpuscular Hemoglobin

Time frame:8-weeks

change from baseline, event

Secondary/protocol endpoint

Safety Labs - Change in Metabolic Parameters (g/dl)

Time frame:8 weeks

change from baseline, event

Secondary/protocol endpoint

Safety Labs - Change in Hematocrit

Time frame:8 weeks

change from baseline, event

Secondary/protocol endpoint

Safety Labs - Change in Monocytes

Time frame:8 weeks

change from baseline, event

Secondary/protocol endpoint

Safety Labs - Change in Red Cell Distribution Width

Time frame:8 weeks

change from baseline, event

Secondary/protocol endpoint

Safety Labs - Change in Hemoglobin A1c

Time frame:8 weeks

change from baseline, event

Secondary/protocol endpoint

Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl)

Time frame:8 weeks

change from baseline, event

Secondary/protocol endpoint

Safety Labs - Change in Sodium and Potassium (mmol/L)

Time frame:8 weeks

change from baseline, event

Secondary/protocol endpoint

Safety Labs - Change in Liver Panel (iU/L)

Time frame:8 weeks

change from baseline, event

Secondary/registry result

Adverse Events

Time frame:Baseline to 8 weeks

event count, event

Posted result

GroupValue (number), EventsReported bounds
RAPA Interventionn=10 Participants20-
Secondary/registry result

Safety Labs - Change in White Blood Cell and Platelet Counts From Baseline to 8 Weeks

Time frame:Baseline to 8 weeks

change from baseline, event

Posted result

GroupValue (mean), x10^3 cells/μLStandard deviation
RAPA InterventionWhite Blood Cell Countn=10 Participants0.421.92
Immature Granulocytesn=10 Participants-0.211.19
Eosinophilsn=10 Participants0.102.5
Basophilsn=10 Participants-0.190.40
Plateletsn=10 Participants20.6035.19
Secondary/registry result

Safety Labs - Change in Red Blood Cell Count

Time frame:Baseline to 8 weeks

change from baseline, event

Posted result

GroupValue (mean), x10^6 cells/μLStandard deviation
RAPA Interventionn=10 Participants-0.010.27
Secondary/registry result

Safety Labs - Change in Mean Corpuscular Volume

Time frame:8 weeks

change from baseline, event

Posted result

GroupValue (mean), fLStandard deviation
RAPA Interventionn=10 Participants-2.702.16
Secondary/registry result

Safety Labs - Change in Mean Corpuscular Hemoglobin

Time frame:8-weeks

change from baseline, event

Posted result

GroupValue (mean), pgStandard deviation
RAPA Interventionn=10 Participants-0.810.69
Secondary/registry result

Safety Labs - Change in Metabolic Parameters (g/dl)

Time frame:8 weeks

change from baseline, event

Posted result

GroupValue (mean), g/dlStandard deviation
RAPA InterventionHemoglobinn=10 Participants-0.270.57
Proteinn=10 Participants-1.775.85
Albuminn=10 Participants-0.130.19
Mean Corpuscular Hemoglobin Concentrationn=10 Participants0.080.85
Secondary/registry result

Safety Labs - Change in Hematocrit

Time frame:8 weeks

change from baseline, event

Posted result

GroupValue (mean), percentage of red blood cellsStandard deviation
RAPA Interventionn=10 Participants-0.862.09
Secondary/registry result

Safety Labs - Change in Monocytes

Time frame:8 weeks

change from baseline, event

Posted result

GroupValue (mean), percentage of white blood cell countStandard deviation
RAPA Interventionn=10 Participants-0.194.08
Secondary/registry result

Safety Labs - Change in Red Cell Distribution Width

Time frame:8 weeks

change from baseline, event

Posted result

GroupValue (mean), PercentageStandard deviation
RAPA Interventionn=10 Participants-0.650.24
Secondary/registry result

Safety Labs - Change in Hemoglobin A1c

Time frame:8 weeks

change from baseline, event

Posted result

GroupValue (mean), % of hemoglobin covered w/ glucoseStandard deviation
RAPA Interventionn=10 Participants0.170.22
Secondary/registry result

Safety Labs - Change in Metabolic and Lipid Parameters (mg/dl)

Time frame:8 weeks

change from baseline, event

Posted result

GroupValue (mean), mg/dlStandard deviation
RAPA Interventionglucosen=10 Participants2.706.67
blood urea nitrogenn=10 Participants-1.804.13
Creatininen=10 Participants-0.0010.09
Bilirubinn=10 Participants-0.090.34
Cholesteroln=10 Participants-0.3026.08
High-Density Lipoprotein Cholesteroln=10 Participants2.907.22
Low-Density Lipoprotein Cholesteroln=10 Participants-2.7020.38
Very Low-Density Lipoprotein Cholesteroln=10 Participants-0.504.25
Secondary/registry result

Safety Labs - Change in Sodium and Potassium (mmol/L)

Time frame:8 weeks

change from baseline, event

Posted result

GroupValue (mean), mmol/LStandard deviation
RAPA InterventionSodiumn=10 Participants-5.4018.90
Potassiumn=10 Participants-0.190.44
Secondary/registry result

Safety Labs - Change in Liver Panel (iU/L)

Time frame:8 weeks

change from baseline, event

Posted result

GroupValue (mean), IU/LStandard deviation
RAPA InterventionAspartate Aminotransferasen=10 Participants1.004.06
Alanine Transaminasen=10 Participants0.0016.20
Alkaline Phosphatasen=10 Participants4.1010.90

Other clinical outcomes

4 endpoints
Secondary/protocol endpoint

Cognition/Functional Status - Change on Grip Strength, Dominant Hand

Time frame:8 weeks

categorical status, descriptive

Secondary/protocol endpoint

Cognition/Functional Status - Change on Grip Strength, Non-dominant Hand

Time frame:8 weeks

categorical status, descriptive

Secondary/registry result

Cognition/Functional Status - Change on Grip Strength, Dominant Hand

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), kilogramsStandard deviation
RAPA Interventionn=10 Participants0.302.10
Secondary/registry result

Cognition/Functional Status - Change on Grip Strength, Non-dominant Hand

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), kilogramsStandard deviation
RAPA Interventionn=10 Participants-0.253.30

Other (unclassified)

18 endpoints
Secondary/protocol endpoint/low confidence

Change in Vitals From Baseline to 8 Weeks

Time frame:Baseline to 8 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of Study Drug Pills Taken

Time frame:Baseline to 8 weeks

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Change in Plasma AD Biomarkers From Baseline to 8 Weeks

Time frame:Baseline to 8 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Plasma Inflammatory Markers From Baseline to 8 Weeks

Time frame:Baseline to 8 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Cognition/Functional Status - Change on the Clinical Rating Scale Global Score

Time frame:8 weeks

categorical status, descriptive

Secondary/protocol endpoint/low confidence

Cognition/Functional Status - Change on the Clinical Rating Scale Sum of Boxes Score

Time frame:8 weeks

categorical status, descriptive

Secondary/protocol endpoint/low confidence

Cognition/Functional Status - Change on the Benson Figure Copy

Time frame:8 weeks

categorical status, descriptive

Secondary/protocol endpoint/low confidence

Cognition/Functional Status - Change on Phonemic Fluency

Time frame:8 weeks

ratio, descriptive

Secondary/protocol endpoint/low confidence

Cognition/Functional Status - Change on the Hayling, Total Errors

Time frame:8 weeks

categorical status, descriptive

Secondary/registry result/low confidence

Change in Vitals From Baseline to 8 Weeks

Time frame:Baseline to 8 weeks

change from baseline, improvement

Posted result

GroupValue (mean), mmHgStandard deviation
RAPA Interventionsystolic blood pressuren=10 Participants10.457.82
diastolic blood pressuren=10 Participants1.75.87
Secondary/registry result/low confidence

Percentage of Study Drug Pills Taken

Time frame:Baseline to 8 weeks

threshold achievement, improvement

Posted result

GroupValue (mean), percentage of study drug pills takenStandard deviation
RAPA Interventionn=10 Participants925
Secondary/registry result/low confidence

Change in Plasma AD Biomarkers From Baseline to 8 Weeks

Time frame:Baseline to 8 weeks

change from baseline, improvement

Posted result

GroupValue (mean), ng/mlStandard deviation
RAPA Interventionplasma ptau-181n=10 Participants-0.220.47
plasma abeta 40n=10 Participants-8.8612.28
Plasma Abeta42n=10 Participants-0.670.69
Plasma GFAPn=10 Participants-27.7064.78
Plasma NFLn=10 Participants0.844.64
Secondary/registry result/low confidence

Change in Plasma Inflammatory Markers From Baseline to 8 Weeks

Time frame:Baseline to 8 weeks

change from baseline, improvement

Posted result

GroupValue (mean), pg/mlStandard deviation
RAPA InterventionIL-10n=10 Participants-0.180.53
IL-6n=10 Participants0.290.54
IL-8n=10 Participants0.161.57
TNF-αn=10 Participants0.060.44
IL-12n=10 Participants-16.5638.52
IL-15n=10 Participants0.120.31
IL-16n=10 Participants16.1842.70
IL-17an=10 Participants0.361.68
IL-1an=10 Participants-0.200.36
IL-5n=10 Participants0.340.46
IL-7n=10 Participants-0.141.63
VEGF-An=10 Participants-0.057.98
VEGF-Cn=10 Participants2000.386648.40
VEGF-Dn=10 Participants3741.023124.38
Eotaxinn=10 Participants22.0736.04
Eotaxin-3n=10 Participants-3.606.19
IP-10n=10 Participants18.2680.08
MCP-1n=10 Participants-4.8010.74
MIP1-αn=10 Participants-0.833.64
sFLT-1n=10 Participants258.88237.44
PIGFn=10 Participants20.8111.81
bFGFn=10 Participants-143.67174.71
sVCAM1n=10 Participants97456.611400309.82
sICAM1n=10 Participants91844.331329185.57
SAAn=10 Participants190090000936172849.0
CRPn=10 Participants36165816.2111516450.7
IFN-γn=10 Participants4.371.91
Secondary/registry result/low confidence

Cognition/Functional Status - Change on the Clinical Rating Scale Global Score

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants0.150.16
Secondary/registry result/low confidence

Cognition/Functional Status - Change on the Clinical Rating Scale Sum of Boxes Score

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants0.550.86
Secondary/registry result/low confidence

Cognition/Functional Status - Change on the Benson Figure Copy

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants0.701.83
Secondary/registry result/low confidence

Cognition/Functional Status - Change on Phonemic Fluency

Time frame:8 weeks

ratio, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants1.803.71
Secondary/registry result/low confidence

Cognition/Functional Status - Change on the Hayling, Total Errors

Time frame:8 weeks

categorical status, descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
RAPA Interventionn=10 Participants0.0010.78

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.