WithdrawnPhase 1

A FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine) for the Treatment of Participants With Mild to Moderate Alzheimer's Disease

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety, Tolerability, Pharmacokinetics, and Brain Metabolic Response, Using FDG-PET, Following Administration of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine) in Participants With Mild to Moderate Alzheimer's Disease

Lead sponsor

Allergan

Assets

AGN-242071 / Donepezil / Memantine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•AD symptomatic therapy: stable ≥6 weeks

Primary endpoints

•Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Metabolic Measure•Treatment-Emergent Adverse Events (TEAE)•Changes from Baseline in Clinically Significant Clinical Laboratory Values

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 ID3142-101-001

NCT IDNCT03316898

Timeline

Milestones

Study first posted2017-10-20actual

Study start2018-09-30estimated

Last update posted2018-11-02actual

Primary completion2018-11-04estimated

Study completion2018-11-04estimated

Assets

Drug assets

AGN-242071 Donepezil Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnostic evidence of probable Alzheimer's Disease (AD) per the 2011 National Institutes of Aging-Alzheimer's Association (NIA-AA) criteria

•Participants receiving donepezil at a stable dose of 10 mg daily with or without stable dose memantine for at least 6 weeks prior to the screening visit

Exclusion criteria

•Participants with illness apart from AD that could contribute to cognitive dysfunction

•History of clinically significant suicidal ideation within the past 6 months

•Thyroid disease unless the participant is euthyroid and stable on treatment for at least 3 months prior to screening

•Participants with a personal or family history of congenital long QT syndrome or sudden death

•Clinically significant cardiovascular disease in the past 6 months prior to screening

•Participants with signs and symptoms of peripheral vascular disease (PVD)

•A transient ischemic attack or other acute ischemic event affecting the brain, spinal cord, or peripheral circulation in the past 6 months prior to screening

•Any history of cerebrovascular accident or stroke

•Any history of a seizure disorder other than a single febrile seizure

•Pulmonary disease or evidence of clinically significant moderate or severe pulmonary symptoms

•History of cancer within the last 5 years

•Evidence or history of diabetes mellitus Type 1

•Any significant sensory (eg, moderate to severely impaired hearing or severely impaired vision) or hand movement difficulties that would prevent participants from completing the behavioral assessments of the study

•Treatment with cholinesterase inhibitors other than donepezil or other cholinomimetics within 12 weeks of the baseline visit

•Treatment with memantine not in combination with donepezil within 12 weeks of the baseline Visit

•Participants who have been on anticholinergic and/or antimuscarinic treatment including overactive bladder treatments, antihistamines, antipsychotics, and tricyclic antidepressants, within 12 weeks prior to the baseline visit

•Participants who have been on drugs that are strong inhibitors of CYP2D6 or CYP2C9 (eg, quinidine, paroxetine, fluoxetine, terbinafine, bupropion), or that are moderate or strong inhibitors of CYP3A4 (eg, erythromycin, ketoconazole, rifampicin, fluconazole, carbamazepine) within 21 days prior to the baseline visit

•Participants who are taking any moderate or strong inducers of CYP3A4 (eg, carbamazepine, phenytoin, rifampin, modafinil, and herbal preparations containing St. John's wort) or strong inducers of CYP2C9 within 21 days prior to the baseline visit

•Participants who have been on other drugs that could affect cognition (eg, benzodiazepines or gamma-aminobutyric acid A (GABAA) receptor agonists used as anxiolytics, sedative-hypnotics) or over-the-counter (OTC) sleeping aids within 12 weeks prior to the baseline visit

•Participants who have been on hormone replacement therapy, thyroid supplement, vitamin E, or vitamin B12 unless at a stable dose for 4 weeks before the baseline visit

•Use of an active Alzheimer's disease vaccine within 2 years prior to screening or monoclonal antibody for treatment of AD within 1 year prior to screening

•Positive test results for anti-human immunodeficiency virus (anti-HIV) type 1 and 2, hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (anti-HCV) at screening

•Positive test results for urine drug screen for methadone, cocaine, tetrahydrocannabinol, benzodiazepines, tricyclic antidepressants, barbiturates, phencyclidine, amphetamines, methamphetamine, and opiates at screening or baseline visit

•Participants with a body weight of less than 40 kg

•Consumption of food or drinks containing grapefruit juice, cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville orange or of alcohol within 72 hours before administration of study treatment.

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

Safety / tolerability / PK

Behavior / neuropsychiatric

Neuroimaging

Other (unclassified)

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

Percentage of Participants who have Suicidal Ideation or Behaviours as determined by Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:Baseline (Day 1) to Day 35

threshold achievement, improvement

Neuroimaging

1 endpoint

Primary/protocol endpoint

Change from Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Metabolic Measure of Standard Uptake Value Ratio (SUVR) for Whole Brain, Hippocampal and Dorsolateral Prefrontal Cortices

Time frame:Baseline (Day -3 to Day -1) to Day 28

change from baseline, improvement

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

Percentage of Participants with Treatment-Emergent Adverse Events (TEAE)

Time frame:Day 1 to Day 35

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants with Changes from Baseline in Clinically Significant Clinical Laboratory Values

Time frame:Baseline (Day -3 to Day -1) to Day 35

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants with Changes from Baseline in Clinically Significant Vital Signs

Time frame:Baseline (Day -3 to Day -1) to Day 35

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants with Changes from Baseline in Clinically Significant Electrocardiogram (ECG) Findings

Time frame:Baseline (Day -3 to Day -1) to Day 35

threshold achievement, event

Primary/protocol endpoint

Clearance of AGN-242071

Time frame:Day 1 to Day 28

descriptive

Primary/protocol endpoint

Cmax: Maximum Plasma concentration for AGN-242071

Time frame:Day 28

concentration, descriptive

Primary/protocol endpoint

AUC: Area Under the Curve for AGN-242071

Time frame:Day 28

concentration, descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Volume of Distribution of AGN-242071

Time frame:Day 1 to Day 28

descriptive

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.