← Trials/Trial dossier/NCT05227820

CompletedPhase 2Results posted

Insulin-Sensitizing Anti-Inflammatory Small Molecule for Investigative Treatment of Dementia

Anti-Inflammatory, Insulin-Sensitizing Agent for Treatment of Cognitive Decline Due to Degenerative Dementias

Lead sponsor

Neurological Associates of West Los Angeles

Asset

NE3107

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 55-89

Primary endpoint

•FMRI

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 IDBiovie & Dementia

NCT IDNCT05227820

Timeline

Milestones

Study start2022-01-19actual

Study first posted2022-02-07actual

Primary completion2022-07-20actual

Study completion2022-08-20actual

Last update posted2024-07-09actual

Results first posted2024-07-09actual

Assets

Drug assets

NE3107

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age89 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

In order for a subject to be considered for this study, the following criterion is required:

Inclusion Criteria:

•Cognitive decline with Clinical Dementia Rating (CDR) score of 0.5 to 1, suggesting mild cognitive impairment to mild dementia.

•Participants must be between the ages of 50-89

•Primary cognitive complaint must be memory Impairment without movement or psychiatric explanation/diagnosis

•Participants must show at least one abnormal imaging biomarker and none of the exclusion criteria below

Exclusion criteria

In order for a subject to be considered for this study, he/she may NOT have any of the following:

•Subjects with contraindications for lumbar puncture, such as bleeding abnormalities, use of anticoagulant medications, and local skin or spine abnormalities

•Reversible causes of cognitive impairment that explains the clinical status entirely, such as hypothyroidism, depression

•Advanced stages of any terminal illness or any active cancer that requires chemotherapy

•History of breast cancer

•Women with child-bearing potential who are not willing to use a double-barrier birth control method

•Males not willing to use a double-barrier birth control method with female sex partners with child-bearing potential

Endpoints (10)

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

Global cognition

Neuroimaging

Global cognition

8 endpoints

Secondary/protocol endpoint

Clinical Dementia Rating Change as Calculated From the Quick Dementia Rating Scale Change

Time frame:3 Months

descriptive

Secondary/protocol endpoint

Montreal Cognitive Assessment (MoCA) Change

Time frame:3 Months

Montreal Cognitive Assessment (MoCA)

categorical status, descriptive

Secondary/protocol endpoint

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Change

Time frame:3 Months

ADAS-Cog

descriptive

Secondary/protocol endpoint

Mini-Mental State Examination (MMSE) Change

Time frame:3 Months

Mini-Mental State Examination (MMSE)

descriptive

Secondary/registry result

Clinical Dementia Rating Change as Calculated From the Quick Dementia Rating Scale Change

Time frame:3 Months

descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Experimental Arm: NE3107n=23 Participants	14	-

Secondary/registry result

Montreal Cognitive Assessment (MoCA) Change

Time frame:3 Months

Montreal Cognitive Assessment (MoCA)

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Experimental Arm: NE3107n=23 Participants	9	-

Secondary/registry result

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Change

Time frame:3 Months

ADAS-Cog

descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Experimental Arm: NE3107n=23 Participants	13	-

Secondary/registry result

Mini-Mental State Examination (MMSE) Change

Time frame:3 Months

Mini-Mental State Examination (MMSE)

descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Experimental Arm: NE3107n=23 Participants	8	-

Neuroimaging

2 endpoints

Primary/protocol endpoint

Change in fMRI

Time frame:3 Months

change from baseline, improvement

Primary/registry result

Change in fMRI

Time frame:3 Months

change from baseline, improvement

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Experimental Arm: NE3107n=23 Participants	11	-

Publications (36)

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.