CompletedPhase 2

Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment

A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Effect on Cognitive Function of AL-108 After 12 Weeks of Intranasal Administration in Subjects With Mild Cognitive Impairment

Lead sponsor

Allon Therapeutics

Asset

Davunetide

Listed sites

Recruiting sites

Enrollment

144

actual

Study population

MCI / preclinical Alzheimer’s

Key I/E criterion

•MMSE ≥24

Primary endpoint

•Change

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 IDAL-108-211

NCT IDNCT00422981

Timeline

Milestones

Study start2007-01 (month precision)

Study first posted2007-01-17estimated

Primary completion2008-01actual (month precision)

Study completion2008-01actual (month precision)

Last update posted2012-10-24estimated

Assets

Drug assets

Davunetide

Study populations

Who this study enrolls

MCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Is male or female, at 55-85 years of age (inclusive) at screening

•Self-reported memory complaint, corroborated by spouse or companion as appropriate.

•Wechsler Memory Scale III (WMS-III) age-adjusted Logical Memory II score ≤ 5.

•Mini-Mental State Exam (MMSE) ≥24.

•Center for Epidemiologic Studies-Depression (CES-D) score <27.

•Normal thyroid function, defined as TSH, T3 and T4 within normal limits.

•Agree not to consume alcoholic beverages within 8 hours of each study visit.

•Willing and able to sign informed consent and complete the CTB and all other tests and procedures as listed in the protocol.

•Fluently reads and speaks English.

•Female subjects must be surgically sterile or post-menopausal for at least 2 years. If <2 years post-menopausal, then a follicle stimulating hormone (FSH) ≥40 mIU/mL must be obtained

Exclusion criteria

•Subjects who have any significant, untreated psychiatric illness or any CNS condition (such as schizophrenia, Parkinson's disease, stroke, etc.) that could interfere with the study evaluations or procedures or which poses an additional risk. Subjects with a history of uncomplicated depression may participate if in remission and on a stable dose of antidepressant medication for at least 2 months.

•History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.

•History of alcohol or substance abuse or dependence within the past year.

•Acute infective sinusitis.

•History or presence of an abnormality of the external or internal structures of the nose or nasopharynx, except for surgical correction of the nasal septum or a "broken nose" at least 2 years previously, or surgical repair of cleft palate when <30 years of age.

•Use of medications that are known to cause frank obtundation of cognition

•Use of any approved or investigational medication for Alzheimer's Disease within 3 months of screening

•History of or current significant systemic disease judged to interfere with the study evaluations or likely to be a safety concern.

•Untreated sleep apnea or treatment for sleep apnea for <3 months.

•Abnormal clinical laboratory test results, specifically: Alanine transaminase (ALT) or aspartate transaminase (AST) >2 х the upper limit of normal (ULN),Hematology <80% the lower limit of normal, Creatinine ≥2 mg/dL and ,Other clinical laboratory values or vital signs considered clinically significant in the opinion of the Investigator.

•Treatment with any investigational drug, biologic, or device within the previous 30 days prior to screening.

•Surgery involving general anesthesia within the past 3 months or planned surgery requiring general anesthesia during the study period.

Endpoints (3)

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

Memory

Other (unclassified)

Memory

2 endpoints

Primary/protocol endpoint

Change from baseline to Week 12 on the Composite Memory Variable

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16

Time frame:16 weeks

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16).

Time frame:16 weeks

descriptive

Publications (2)

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.