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Monoclonal Antibodies

Solanezumab for Cognitive Disorders (A4 Trial)

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 336
Awards & highlights

A4 Trial Summary

This trial will test whether the drug solanezumab can slow the progression of memory problems for people with Alzheimer's Disease.

A4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 336
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 336 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score
Secondary outcome measures
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score
Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
Change From Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers
+5 more

Side effects data

From 2023 Phase 3 trial • 1169 Patients • NCT02008357
27%
Covid-19
17%
Fall
11%
Upper respiratory tract infection
10%
Arthralgia
9%
Urinary tract infection
6%
Headache
6%
Back pain
5%
Pain in extremity
5%
Squamous cell carcinoma
5%
Cataract
5%
Dizziness
4%
Hypertension
4%
Sinusitis
4%
Diarrhoea
4%
Anxiety
3%
Contusion
3%
Nasopharyngitis
3%
Bronchitis
3%
Rash
3%
Vertigo
3%
Vaccination complication
3%
Basal cell carcinoma
3%
Cognitive disorder
3%
Nausea
3%
Osteoarthritis
3%
Skin laceration
2%
Ligament sprain
2%
Cough
2%
Muscle strain
2%
Chest pain
2%
Gastrooesophageal reflux disease
2%
Arthritis
2%
Dermatitis contact
2%
Herpes zoster
2%
Fatigue
2%
Cellulitis
2%
Oedema peripheral
2%
Benign prostatic hyperplasia
2%
Constipation
2%
Conjunctivitis
2%
Myalgia
2%
Cerebral microhaemorrhage
2%
Depression
2%
Insomnia
1%
Atrial fibrillation
1%
Influenza
1%
Paraesthesia
1%
Arthropod bite
1%
Post procedural haemorrhage
1%
Sciatica
1%
Muscle spasms
1%
Pruritus
1%
Abdominal discomfort
1%
Tooth infection
1%
Dyspnoea
1%
Hypercholesterolaemia
1%
Cardiac failure congestive
1%
Acute myocardial infarction
1%
Humerus fracture
1%
Hip fracture
1%
Femur fracture
1%
Prostate cancer
1%
Urinary retention
1%
Balance disorder
1%
Hypotension
1%
Bursitis
1%
Skin abrasion
1%
Osteoporosis
1%
Seasonal allergy
1%
Gastroenteritis
1%
Viral upper respiratory tract infection
1%
Rotator cuff syndrome
1%
Pneumonia
1%
Memory impairment
1%
Actinic keratosis
1%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Solanezumab: Double-blind (Placebo Controlled) Period
Placebo: Double-blind (Placebo Controlled) Period
Solanezumab/Solanezumab: Open-label Extension Period
Placebo/Solanezumab: Open-label Extension Period

A4 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Solanezumab/SolanezumabExperimental Treatment1 Intervention
Participants received 400 milligram (mg) solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered intravenously (IV) every 4 weeks (Q4W) for approximately 240 weeks in double-blind placebo-controlled period. Participants begin open label extension and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).
Group II: Placebo/SolanezumabPlacebo Group2 Interventions
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind period. Participants begin open label extension period and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Solanezumab
2014
Completed Phase 3
~1400

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,622 Previous Clinical Trials
3,215,606 Total Patients Enrolled
Alzheimer's Therapeutic Research InstituteOTHER
16 Previous Clinical Trials
57,636 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
414,729 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have other patients undergone this type of treatment before?

"To date, there has been one large-scale study of Solanezumab that spanned 51 cities and 4 countries. This global study, which was sponsored by Eli Lilly and Company, was a Phase 3 drug approval stage trial that concluded in 2014. In the years since the initial study, 18269 smaller studies have been completed."

Answered by AI

What is the FDA's legal stance on Solanezumab?

"There is some evidence that Solanezumab is effective, as it has reached Phase 3 in clinical trials. Furthermore, multiple rounds of testing have confirmed its safety, and thus it receives a score of 3."

Answered by AI

What is the largest patient group size for this medical study?

"This specific clinical trial is not recruiting patients at this time, as the last edit was made on 8/17/2022. There are, however, other studies that may be of interest. There are currently 56 clinical trials with open recruitment and 1 study for Solanezumab that is actively seeking participants."

Answered by AI

Could you please provide a rundown of other studies that have included Solanezumab?

"The antibody drug solanezumab was first studied in 2014 at Boston University Medical Center. Out of the 18,269 completed trials, 1 is actively recruiting patients. This particular study has a large number of sites in New york, New York."

Answered by AI

Would this program consider elderly citizens as participants?

"The age parameters for this clinical trial are 65 and 85 years old, meaning that all participants must fall within this range."

Answered by AI

Could I possibly be a subject in this experiment?

"To participate in this study, elderly patients must meet the overinclusion criteria and be between 65 and 85 years old. So far, 1150 have been accepted."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
NeurologyJournal
Associations of Stages of Objective Memory Impairment with Amyloid PET and Structural MRI
Grober, Ellen, Richard B. Lipton, Reisa A. Sperling, Kathryn V. Papp, Keith A. Johnson, Dorene M. Rentz, Amy E. Veroff, Paul S. Aisen, and Ali Ezzati. 2022. “Associations of Stages of Objective Memory Impairment with Amyloid PET and Structural MRI”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/wnl.0000000000200046.
The Journal Of Prevention of Alzheimer's DiseaseJournal
Anxiety and Depressive Symptoms and Cortical Amyloid-β Burden in Cognitively Unimpaired Older Adults
Lewis, C.K., O.M. Bernstein, J.D. Grill, D.L. Gillen, and D.L. Sultzer. 2022. “Anxiety and Depressive Symptoms and Cortical Amyloid-β Burden in Cognitively Unimpaired Older Adults”. The Journal of Prevention of Alzheimer's Disease. SERDI. doi:10.14283/jpad.2022.13.
clinicaltrials.govStudy
Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss
2014. "Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02008357.
~105 spots leftby May 2025
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