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Find more clinical trials

ACI-24 Vaccine in Adults with Down Syndrome

Start: March 2016
End: June 2020
Enrollment: 24

What Is This Study About?

This Phase I study will test the ACI-24 vaccine in adults with Down syndrome to assess whether the vaccine is safe, tolerable, and able to stimulate an immune response.

Do I Qualify To Participate in This Study?

Minimum Age: 25 Years

Maximum Age: 45 Years

Must have:

  • Down syndrome, with either Trisomy 21 or Complete Unbalanced Translocation of the Chromosome 21
  • Subjects and their study partner/legal representative are able to understand and provide written informed consent
  • Sufficiently proficient in English to complete study assessments
  • Caregiver/partner who has direct contact with participant at least 10 hours per week and can answer questions about him or her

Must NOT have:

  • Weight of less than 40 kg (88 pounds)
  • IQ of less than 40, as assessed by Kaufman Brief Intelligence Test, Second Edition
  • Current psychiatric or neurological diagnosis other than Down syndrome
  • Any medical condition likely to significantly hamper the safety evaluation of the study drug
  • Drug or alcohol abuse or dependence within the past 5 years
  • History or presence of uncontrolled seizures
  • History of malignant neoplasms within 3 years before study entry or current evidence of recurrent or metastatic disease
  • History of persistent cognitive deficits immediately following head trauma
  • History of inflammatory neurological disorders
  • History of autoimmune disease with potential for central nervous system involvement
  • Magnetic resonance imaging scan at screening showing single area of cerebral vasogenic edema, superficial siderosis, evidence of prior macrohemorrhage, or more than four cerebral microhemorrhages
  • MRI examination cannot be done for any reason, including metal implants in body or severe claustrophobia
  • Significant hearing or visual impairment or other issues that could interfere with completing the trial
  • Severe infections or major surgery within past 3 months
  • History of chronic or recurrent infections, or immunological or inflammatory conditions that could hamper interpretation of safety
  • Celiac disease not on a gluten free diet for at least 3 months prior to screening
  • Chronic benign skin pathologies, unless viewed as clinically insignificant
  • Any vaccine received within the past 2 months, except influenza vaccine if given at least 2 weeks prior to baseline
  • Clinically significant arrhythmias or other major abnormalities shown on electrocardiogram
  • Clinically significant abnormal vital signs, including sustained sitting blood pressure greater than 160/90 mmHg; clinically significant abnormal hematology and biochemistry values
  • Treated hypothyroidism not on a stable dose of medication for at least 3 months prior to screening; clinically significant abnormal serum T-4 and TSH at screening
  • Diabetes mellitus with an HbA1c of 8% or greater at baseline
  • Receiving any experimental drug for Down syndrome with a washout less than 30 days or less than five half-lives of the drug, whichever is longer
  • Women who are pregnant, breastfeeding, or not using a reliable method of contraception
  • Prohibited medications: any anticoagulant drug or aspirin at doses greater than 100 mg daily; antidepressant other than SSRI/SNRI at stable dose; antipsychotic (low doses of atypical antipsychotics or benzodiazepines may be allowed); GABA agonists such as gabapentin; stimulant; immunosuppressant or immunomodulating drugs or their use within the past 6 months; steroids within the past 3 months; cholinesterase inhibitor or glutamatergic drug if not on stable dose for at least 3 months prior to screening
  • Donated blood or blood products during 30 days before screening and/or plan to donate blood during the study or within 4 weeks after the study

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: AC Immune SA

Collaborator Sponsor

  • National Institute on Aging (NIA)
  • Alzheimer's Disease Cooperative Study (ADCS)
  • LuMind Research Down Syndrome Foundation

Source: ClinicalTrials.gov ID: NCT02738450

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