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?
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
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?
Collaborator Sponsor
-
National Institute on Aging (NIA)
-
Alzheimer's Disease Cooperative Study (ADCS)
-
LuMind Research Down Syndrome Foundation
Source:
ClinicalTrials.gov ID:
NCT02738450