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AC-1204 for Mild to Moderate Alzheimer's Disease

Start: March 2013
End: April 14, 2017
Enrollment: 480

What Is This Study About?

This study will evaluate the effects of the compound AC-1204 on cognition, activities of daily living, quality of life, pharmacokinetic measures, and safety in people with mild to moderate Alzheimer's disease.

Do I Qualify To Participate in This Study?

Minimum Age: 66 Years

Maximum Age: 90 Years

Must have:

  • Probable mild to moderate Alzheimer's dementia, with evidence from CT or MRI scan within the past 18 months and Wechsler Memory Scale-Logical Memory II score (CT or MRI scan may be conducted as part of the screening procedure)
  • Confirmed apolipoprotein E genotype prior to randomization
  • Stable medical condition, with the exception of dementia, for at least 3 consecutive months prior to screening
  • Permanent, English- or Spanish-speaking caregiver (not expected to change during the course of the study) who is willing to attend all visits, oversee the participant's compliance with study procedures, and report the participant's status
  • Community dwelling (includes assisted living facilities but excludes long-term care nursing facilities)
  • Ability to read and write in English or Spanish
  • Hearing, vision, and physical abilities adequate to perform the assessments
  • Ability to ingest oral medication; prior and current use of medication that corresponds with protocol requirements
  • Informed consent by participant or cognitively intact, legally acceptable representative 

Must NOT have:

  • Cause of dementia other than Alzheimer's disease, as determined by CT or MRI scan within the past 18 months
  • Prohibited medications: medium-chain, triglyceride-containing products; use of any other investigational agent within 60 days prior to screening
  • Known allergy or hypersensitivity to milk or soy products
  • Presence or history of advanced, severe, progressive or unstable disease of any type that could interfere with the study or put the participant at risk
  • History or clinical laboratory evidence of moderate congestive heart failure; clinically significant ECG abnormalities at screening; history of new cardiovascular events within 6 months before baseline
  • Systolic blood pressure (top number) of more than 165 mmHg; diastolic blood pressure (bottom number) of more than 95 mmHg; or drop of 20 mm Hg or more in systolic blood pressure upon standing upright from a seated position within 3 minutes at screening
  • History of or current psychiatric illness, including: major depression, active suicidal thoughts within 6 months of screening, suicide attempt in the past 2 years; history of alcohol or drug abuse within the past 6 months
  • Insulin-dependent diabetes
  • Clinically significant anemia; clinically significant renal disease or insufficiency; history of severe liver disease or results of liver-function tests more than 2.5 times the upper limit of normal
  • Fasting triglycerides are more than 2.5 times the upper limit of normal
  • Clinically significant vitamin B12 deficiency within the past year
  • History of significant gastrointestinal (GI) disease:
    • Inflammatory bowel disease, GI bleed, or peptic ulcer disease (any history)
    • Complicated reflux disease or severe GERD that is not well-controlled by medication (current history or within past 5 years)
    • Irritable bowel syndrome, diverticular disease, or chronic gastritis (diagnosis or acute event within past 5 years
  • Donation of at least 2 units of blood within the past 2 months
  • History of neoplasm or malignancies within 5 years prior to screening, except for basal cell or squamous cell carcinoma of the skin
  • Clinically significant hypothyroidism
  • Expected hospitalization and/or surgery during the course of 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: Accera, Inc.

Source: ClinicalTrials.gov ID: NCT01741194