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← Trials/Trial dossier/NCT03681691

E2T2D

CompletedPhase 1Results posted

The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women

Asset

Estradiol

Listed sites

1

Recruiting sites

-

Enrollment

12

actual

Study population

Mixed / unspecified dementia

Key I/E criteria

•MoCA ≥25•MRI contraindications excluded

Primary endpoints

•Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)--Whole Brain•FDG PET--Whole Brain•Acetoacetate Uptake (AcAc) PET--Whole Brain

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 IDIRB00049740
NCT IDNCT03681691
NihR21AG054955

Timeline

Milestones

Study first posted2018-09-24actual
Study start2019-05-13actual
Primary completion2021-07-19actual
Study completion2021-07-19actual
Last update posted2022-09-27actual
Results first posted2022-09-27actual

Assets

Drug assets

Estradiol

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age60 Years
Maximum age80 Years
SexFemale
Healthy volunteersAccepted

Inclusion criteria

1. Willing to provide written informed consent

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Female, postmenopausal, aged 60-80

4. Normal results on recommended healthcare screenings (e.g., mammogram, pap smear, colonoscopy)

5. BMI 20-35 kg/m2

6. No evidence of dementia or mild cognitive impairment (MoCA score >25)

7. Able to access reliable transportation to study and intervention visits

Exclusion criteria

1. Use of hormone replacement therapy within the past 3 months

2. History of renal, heart, liver, or neurological disease; head injury with loss of consciousness in the past 5 years; chronic pain, anxiety or depression

3. Presence of medical conditions that might contraindicate estrogen use (e.g., unexplained vaginal bleeding, history of reproductive tissue cancer, thrombosis)

4. Currently taking insulin, metformin, or any other drug or medication judged by the study physician to affect safety or research outcomes of interest

5. Involved in another research study

6. Contraindications for MRI or PET scanning

7. Current smoker

Endpoints (44)

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

Other (unclassified)
16
Memory
14
Neuroimaging
10
Executive function / language
4

Memory

14 endpoints
Secondary/protocol endpoint

Short-Term Memory Composite Score

Time frame:Baseline and Week 8

descriptive

Secondary/protocol endpoint

Executive Function Composite Score

Time frame:Baseline and Week 8

descriptive

Secondary/protocol endpoint

California Verbal Learning Task (CVLT) Long Delay Free Recall

Time frame:Baseline and Week 8

descriptive

Secondary/protocol endpoint

CVLT Short Delay Free Recall

Time frame:Baseline and Week 8

descriptive

Secondary/protocol endpoint

Benton Visual Retention Task (BVRT) Total Score

Time frame:Baseline and Week 8

descriptive

Secondary/protocol endpoint

Prospective Memory

Time frame:Baseline and Week 8

descriptive

Secondary/protocol endpoint

Change in Short-term Memory and Executive Function Composite Scores.

Time frame:Baseline and 8 weeks

change from baseline, improvement

Secondary/registry result

Short-Term Memory Composite Score

Time frame:Baseline and Week 8

descriptive

Posted result

GroupValue (mean), z-scoreStandard deviation
Post Menopausal Women Without DiabetesBaselinen=3 Participants1.040.31
Week 8n=3 Participants1.560.53
Post Menopausal Women With DiabetesBaselinen=6 Participants-0.522.01
Week 8n=6 Participants-0.562.04
Secondary/registry result

Executive Function Composite Score

Time frame:Baseline and Week 8

descriptive

Posted result

GroupValue (mean), z-scoreStandard deviation
Post Menopausal Women Without DiabetesBaselinen=3 Participants0.201.36
Week 8n=3 Participants1.664.83
Post Menopausal Women With DiabetesBaselinen=6 Participants-0.101.78
Week 8n=6 Participants0.305.78
Secondary/registry result

California Verbal Learning Task (CVLT) Long Delay Free Recall

Time frame:Baseline and Week 8

descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
Post Menopausal Women Without DiabetesBaselinen=3 Participants12.04.36
Week 8n=3 Participants12.672.08
Post Menopausal Women With DiabetesBaselinen=6 Participants10.833.25
Week 8n=6 Participants13.172.14
Secondary/registry result

CVLT Short Delay Free Recall

Time frame:Baseline and Week 8

descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
Post Menopausal Women Without DiabetesBaselinen=3 Participants11.672.08
Week 8n=3 Participants12.331.15
Post Menopausal Women With DiabetesBaselinen=6 Participants10.003.91
Week 8n=6 Participants11.673.93
Secondary/registry result

Benton Visual Retention Task (BVRT) Total Score

Time frame:Baseline and Week 8

descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
Post Menopausal Women Without DiabetesBaselinen=3 Participants8.670.58
Week 8n=3 Participants9.330.58
Post Menopausal Women With DiabetesBaselinen=6 Participants6.52.07
Week 8n=6 Participants5.52.51
Secondary/registry result

Prospective Memory

Time frame:Baseline and Week 8

descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
Post Menopausal Women Without DiabetesBaselinen=3 Participants10.671.53
Week 8n=3 Participants10.02.0
Post Menopausal Women With DiabetesBaselinen=6 Participants5.833.97
Week 8n=6 Participants8.171.72
Secondary/registry result

Change in Short-term Memory and Executive Function Composite Scores.

Time frame:Baseline and 8 weeks

change from baseline, improvement

Executive function / language

4 endpoints
Secondary/protocol endpoint

Verbal Fluency (Letters)

Time frame:Baseline and Week 8

descriptive

Secondary/protocol endpoint

Verbal Fluency Score (Fruits and Vegetables)

Time frame:Baseline and Week 8

descriptive

Secondary/registry result

Verbal Fluency (Letters)

Time frame:Baseline and Week 8

descriptive

Posted result

GroupValue (mean), number of correct words generatedStandard deviation
Post Menopausal Women Without DiabetesBaselinen=3 Participants48.6716.50
Week 8n=3 Participants46.3312.58
Post Menopausal Women With DiabetesBaselinen=6 Participants42.679.56
Week 8n=6 Participants41.337.66
Secondary/registry result

Verbal Fluency Score (Fruits and Vegetables)

Time frame:Baseline and Week 8

descriptive

Posted result

GroupValue (mean), number of correct fruits and vegetablesStandard deviation
Post Menopausal Women Without DiabetesBaselinen=3 Participants31.04.36
Week 8n=3 Participants32.677.23
Post Menopausal Women With DiabetesBaselinen=6 Participants28.678.62
Week 8n=6 Participants29.178.28

Neuroimaging

10 endpoints
Primary/protocol endpoint

Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)--Whole Brain

Time frame:Baseline

descriptive

Primary/protocol endpoint

FDG PET--Whole Brain

Time frame:Week 8

descriptive

Primary/protocol endpoint

Acetoacetate Uptake (AcAc) PET--Whole Brain

Time frame:Baseline

descriptive

Primary/protocol endpoint

AcAc PET--Whole Brain

Time frame:Week 8

descriptive

Primary/protocol endpoint

Change in Uptake of Glucose and Ketone Bodies in Whole Brain and Alzheimer's Disease-related Regions of Interest.

Time frame:Baseline and 8 weeks

change from baseline, improvement

Primary/registry result

Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)--Whole Brain

Time frame:Baseline

descriptive

Posted result

GroupValue (mean), micromoles/min/100g tissueStandard deviation
Post Menopausal Women Without Diabetesn=2 Participants12.2811.39
Post Menopausal Women With Diabetesn=6 Participants11.7512.42
Primary/registry result

FDG PET--Whole Brain

Time frame:Week 8

descriptive

Posted result

GroupValue (mean), micromoles/min/100g tissueStandard deviation
Post Menopausal Women Without Diabetesn=2 Participants8.742.59
Post Menopausal Women With Diabetesn=6 Participants6.870.88
Primary/registry result

Acetoacetate Uptake (AcAc) PET--Whole Brain

Time frame:Baseline

descriptive

Posted result

GroupValue (mean), micromoles/min/100g tissueStandard deviation
Post Menopausal Women Without Diabetesn=2 Participants0.0310.009
Post Menopausal Women With Diabetesn=6 Participants0.0240.005
Primary/registry result

AcAc PET--Whole Brain

Time frame:Week 8

descriptive

Posted result

GroupValue (mean), micromoles/min/100g tissueStandard deviation
Post Menopausal Women Without Diabetesn=2 Participants0.0270.003
Post Menopausal Women With Diabetesn=6 Participants0.0280.015
Primary/registry result

Change in Uptake of Glucose and Ketone Bodies in Whole Brain and Alzheimer's Disease-related Regions of Interest.

Time frame:Baseline and 8 weeks

change from baseline, improvement

Other (unclassified)

16 endpoints
Secondary/protocol endpoint/low confidence

Digit Span Forward Total Correct

Time frame:Baseline and Week 8

event count, event

Secondary/protocol endpoint/low confidence

Digit Span Backward Total Correct

Time frame:Baseline and Week 8

descriptive

Secondary/protocol endpoint/low confidence

Finger Tapping Score--Dominant Hand

Time frame:Baseline and Week 8

descriptive

Secondary/protocol endpoint/low confidence

Finger Tapping Score--Non-Dominant Hand

Time frame:Baseline and Week 8

descriptive

Secondary/protocol endpoint/low confidence

Card Rotations Test Score

Time frame:Baseline and Week 8

event count, event

Secondary/registry result/low confidence

Digit Span Forward Total Correct

Time frame:Baseline and Week 8

event count, event

Posted result

GroupValue (mean), number of correct responsesStandard deviation
Post Menopausal Women Without DiabetesBaselinen=3 Participants8.00.0
Week 8n=3 Participants7.672.08
Post Menopausal Women With DiabetesBaselinen=6 Participants7.50.55
Week 8n=6 Participants7.672.07
Secondary/registry result/low confidence

Digit Span Backward Total Correct

Time frame:Baseline and Week 8

descriptive

Posted result

GroupValue (mean), span of numbers recalledStandard deviation
Post Menopausal Women Without DiabetesBaselinen=3 Participants4.01.73
Week 8n=3 Participants6.01.0
Post Menopausal Women With DiabetesBaselinen=6 Participants4.670.82
Week 8n=6 Participants5.332.07
Secondary/registry result/low confidence

Finger Tapping Score--Dominant Hand

Time frame:Baseline and Week 8

descriptive

Posted result

GroupValue (mean), number of tapsStandard deviation
Post Menopausal Women Without DiabetesBaselinen=3 Participants40.474.65
Week 8n=3 Participants40.272.25
Post Menopausal Women With DiabetesBaselinen=6 Participants43.536.45
Week 8n=6 Participants44.075.2
Secondary/registry result/low confidence

Finger Tapping Score--Non-Dominant Hand

Time frame:Baseline and Week 8

descriptive

Posted result

GroupValue (mean), number of tapsStandard deviation
Post Menopausal Women Without DiabetesBaselinen=3 Participants39.44.1
Week 8n=3 Participants42.73.5
Post Menopausal Women With DiabetesBaselinen=6 Participants38.25.6
Week 8n=6 Participants41.76.7
Secondary/registry result/low confidence

Card Rotations Test Score

Time frame:Baseline and Week 8

event count, event

Posted result

GroupValue (mean), score on a scaleStandard deviation
Post Menopausal Women Without DiabetesBaselinen=3 Participants76.035.59
Week 8n=3 Participants89.335.86
Post Menopausal Women With DiabetesBaselinen=6 Participants90.6734.60
Week 8n=6 Participants97.028.71
Other/protocol endpoint/low confidence

Regional Ratio of Ketone/Glucose Uptake

Time frame:Baseline and Week 8

ratio, descriptive

Other/protocol endpoint/low confidence

Number of White Matter Hypertensities

Time frame:Baseline and Week 8

event count, event

Other/protocol endpoint/low confidence

Number of Microbleeds

Time frame:Baseline and Week 8

event count, event

Other_pre_specified/registry result/low confidence

Regional Ratio of Ketone/Glucose Uptake

Time frame:Baseline and Week 8

ratio, descriptive

Other_pre_specified/registry result/low confidence

Number of White Matter Hypertensities

Time frame:Baseline and Week 8

event count, event

Other_pre_specified/registry result/low confidence

Number of Microbleeds

Time frame:Baseline and Week 8

event count, event

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.