CompletedPhase 1

Short Term Efficacy and Safety of Perispinal Administration of Etanercept in Mild to Moderate Alzheimer's Disease

Open Label,Crossover,Pilot Study to Assess the Efficacy & Safety of Perispinal Admin.of Etanercept(Enbrel®) in Comb.w/Nutritional Supplements vs. Nutritional Supplements Alone in Subj. w/Mild to Mod. Alzheimer's Disease Receiving Std. Care.

Lead sponsor

Life Extension Foundation Inc.

Asset

Etanercept

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 11-24•MoCA ≤26•Study partner/caregiver required

Primary endpoint

•Mini-Mental State Examination (MMSE)

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 IDCL025

NCT IDNCT01716637

Timeline

Milestones

Study start2010-02 (month precision)

Study first posted2012-10-30estimated

Primary completion2015-10actual (month precision)

Study completion2016-05actual (month precision)

Last update posted2016-05-12estimated

Assets

Drug assets

Etanercept

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subject is aged 60-85 years

•Subject has a diagnosis of Alzheimer's disease according to the NINCDS- ADRDA criteria (National Institute of Neurological and Communicative Disorders and Stroke NINCDS] and Alzheimer's Disease and Related Disorders Association [ADRDA]).

•Subject is not institutionalized (for example, lives independently, lives independently in a residential home for the elderly, or is a day patient at a care center)

•Subject has a Hachinski Ischemia Score of ≤ 4.

•Subject has a total MoCA score of < 26 at screening.

•Subject has an MMSE score of 11 to 24 at screening.

•Subject has an ADAS-cog score of 12 to 25 at screening.

•Subject has experienced a gradual and progressive cognitive decline in the 6 months before the screening visit.

•Subject provides informed consent to participate in the study or has a legally acceptable representative who provides consent.

•Subject has a responsible caregiver who consents to supporting the subject in his/her study participation (for example, by accompanying the subject on each study visit).

•Subject is surgically sterile, agrees to use an acceptable method of birth control as defined in section 5.4 or, for females, is post- menopausal.

•Subject agrees to stop taking any vitamin, mineral, or dietary supplements he/she is currently taking that have any components of the nutritional supplements utilized in the study at least 7 days before randomization (Visit 2) and agrees to not use any new vitamin, mineral, or dietary supplement product other than those provided by the investigator until after the subject is discharged from the study

Exclusion criteria

•A neurologic disorder, such as seizures, multiple sclerosis, neurodegenerative disorders (eg, Parkinson's disease), or dementia other than Alzheimer's type (including that caused by small strokes or cerebrovascular disease)

•Cognitive impairment from any condition other than Alzheimer's disease, such as that resulting from acute cerebral trauma, cerebral damage due to a lack of oxygen, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor

•Cardiovascular or cerebrovascular disease, such as congestive heart failure, uncontrolled hypertension (BP ≥ 140/90 mmHg at screening), and a history of stroke

•Renal impairment/disease, defined as serum creatinine > 1.5 mg/dL

•Hepatic impairment, defined as Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 3 times the upper limit of normal OR has a history of a positive blood screen for hepatitis B surface antigen or hepatitis C antibody.

•Type I or II diabetes mellitus

•Significant or uncontrolled psychiatric disease

•Gastrointestinal disease, such as active peptic ulcer, gallstones, gallbladder disease, or biliary tract obstruction, or a history of cholecystectomy

•Hematologic disorders

•Pulmonary or lung disorders

•Immune system disorder, such as HIV/AIDS

•History of cancer within 10 years before screening (except localized skin cancer without metastases or in situ cervical cancer)

•History of chronic or recurrent infection (including tuberculosis) OR, in the 7 days before Visit 2 (randomization), any known infection or body temperature > 38.6º C (101.5º F)

•Subject is pregnant or breastfeeding at screening.

•Subject has intolerance or allergy to Enbrel®, latex, or any of Enbrel's components.

•Subject is currently consuming more than 6 standard alcoholic beverages a week. A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor.

•Subject is currently taking and unable or unwilling to stop taking anticoagulant or antiplatelet herbs and supplements such as angelica, clove, danshen, garlic, ginger, ginkgo, Panax ginseng, red clover, or willow for at least 7 days before the randomization visit (Visit 2) and throughout the study.

•Subject is currently taking and unable or unwilling to stop taking any of the prohibited medications in protocol section 5.3.2 for at least 7 days before the randomization visit (Visit 2) and throughout the study.

•Subject had major surgery within the 4 weeks before screening.

•Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.

•Subject is participating or has participated in another research study within 30 days before the screening visit

•Subject or subject's caregiver is unable or unwilling to comply with the study procedures.

Endpoints (11)

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

Safety / tolerability / PK

Global cognition

9 endpoints

Primary/protocol endpoint

Difference in effects of treatment for 6 weeks with etanercept + nutritional supplements versus nutritional supplements alone on the Mini-Mental Status Examination (MMSE) score.

Time frame:16 weeks

Mini-Mental State Examination (MMSE)

categorical status, descriptive

Secondary/protocol endpoint

Difference in the effects of treatment for 6 weeks with etanercept + nutritional supplements versus nutritional supplements alone on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) score.

Time frame:16 weeks

ADAS-Cog

descriptive

Secondary/protocol endpoint

Difference in the effects of treatment for 6 weeks with etanercept + nutritional supplements versus nutritional supplements alone on the Montreal Cognitive Assessment (MoCA) score.

Time frame:16 weeks

Montreal Cognitive Assessment (MoCA)

descriptive

Other/protocol endpoint

Difference in the effects of treatment for 6 weeks as well as an additional 12 weeks following visit 15 with nutritional supplementation alone on the MMSE score.

Time frame:28 weeks

Mini-Mental State Examination (MMSE)

descriptive

Other/protocol endpoint

Difference in short term effects of etanercept on the MMSE score before and two hours after perispinal administration of etanercept.

Time frame:16 weeks

Mini-Mental State Examination (MMSE)

ratio, descriptive

Other/protocol endpoint

Difference in the effects of treatment for 6 weeks as well as an additional 12 weeks following visit 15 with nutritional supplementation alone on the ADAS-cog score.

Time frame:28 weeks

ADAS-Cog

descriptive

Other/protocol endpoint

Difference in the effects of treatment for 6 weeks as well as an additional 12 weeks following visit 15 with nutritional supplementation alone on the MoCA score.

Time frame:28 weeks

Montreal Cognitive Assessment (MoCA)

descriptive

Other/protocol endpoint

Difference in short term effects of etanercept on the ADAS-cog score before and two hours after perispinal administration of etanercept.

Time frame:16 weeks

ADAS-Cog

ratio, descriptive

Other/protocol endpoint

Difference in short term effects of etanercept on the MoCA score before and two hours after perispinal administration of etanercept.

Time frame:16 weeks

Montreal Cognitive Assessment (MoCA)

ratio, descriptive

Safety / tolerability / PK

2 endpoints

Other/protocol endpoint

To determine the safety and tolerability of nutritional supplements with perispinal adminstration of etanercept, as measured by various laboratory markers, vital signs (blood pressure and heart rate), and adverse events.

Time frame:16 weeks

event count, event

Other/protocol endpoint

To determine the safety and tolerability of nutritional supplements without perispinal adminstration of etanercept, as measured by various laboratory markers, vital signs (blood pressure and heart rate), and adverse events.

Time frame:16 weeks

event count, event

Publications (34)

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 tableno registry results posted yet

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.