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A 26-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Daily Administration of AC-1204 in Participants With Mild to Moderate Alzheimer's Disease (A

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Trial Conditions
  • Alzheimer's Disease
What is the purpose of this trial?

This study will evaluate the effects of daily dosing of AC-1204 on cognition, activities of daily living, resource utilization, quality of life, pharmacokinetic measures and safety among participants with mild to moderate Alzheimer's Disease.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
66  - 90 

Gender:
Both

Eligibility

Inclusion Criteria:

- Dementia status of mild to moderate

- CT or MRI scan within 18 months prior to screening compatible with a diagnosis of
probable Alzheimer's disease

- Score on the Wechsler Memory Scale - Logical Memory II recall below a pre-determined
cut-off, adjusted for education level

- Confirmed apolipoprotein E genotype prior to randomization

- Prior and current use of medication that corresponds with protocol requirements

- Stable medical condition, with the exception of dementia, for at least 3 consecutive
months prior to screening

- No active suicidal thoughts within 6 months of screening, no active history of
suicide attempt in the previous 2 years, no more than 1 lifetime suicide attempt, no
serious suicidal risk

- Able to comply with protocol testing and procedures for the duration of the study

- Has a permanent caregiver (caregiver is not expected to change during the course of
the study) who is willing to attend all visits, oversee the participant's compliance
with protocol procedures and study medication administration, and report on the
participant's status

- Resides in the community (includes assisted living facilities, but excludes long-term
care nursing facilities)

- Both participant and caregiver have the ability to read and write in English or
Spanish and have hearing, vision and physical abilities adequate to perform the
assessments (corrective aids allowed)

- Participant and caregiver have provided full written informed consent prior to the
performance of any protocol-specified procedure. If participant is unable to provide
informed consent due to cognitive status, provision of informed consent by
cognitively intact legally acceptable representative (where this is in accordance
with local laws, regulations and ethics committee policy)

- Participant is able to ingest oral medication

Exclusion Criteria:

- Current use, or use within 3 months of baseline, of medium-chain
triglyceride-containing products

- Use of any other investigational agent within 9 months prior to screening

- Known allergy or hypersensitivity to milk or soy products

- In the opinion of the investigator, presence or history of advanced, severe,
progressive or unstable disease of any type that could interfere with protocol
assessments or put the participant at particular risk

- Any medical or neurological condition other than Alzheimer's disease that could
explain the patient's dementia

- History or clinical laboratory evidence of moderate congestive heart failure

- Clinically significant ECG abnormalities at screening

- History of new cardiovascular events within 6 months prior to baseline

- History of or current psychiatric illness

- Major depression as determined by Cornell Scale for Depression in Dementia

- Insulin-dependent diabetics

- Systolic blood pressure > 165 mmHg or diastolic blood pressure > 95 mmHg

- Drop of 20 mm Hg systolic blood pressure or greater upon standing upright from a
seated position within 3 minutes at screening

- Clinically significant anemia at screening

- Clinically significant renal disease or insufficiency at screening

- Laboratory values for liver function tests > 2.5 times the upper limit of normal at
screening or history of severe liver disease

- Fasting triglycerides > 2.5 times the upper limit of normal at screening

- Clinically significant B12 deficiency within 12 month prior to screening

- History of inflammatory bowel disease, irritable bowel syndrome, diverticular
disease, chronic gastritis, gastrointestinal bleeding, or severe gastroesophageal
reflex disease requiring ongoing prescription medication

- Has donated ≥ 2 units of blood within the 2 months prior to screening

- History of alcohol or drug abuse within 6 months prior to screening, or positive
urine drug test at screening

- Participant or caregiver is an immediate family member or employee of the clinical
site, sponsor or sponsor's agents

- An alternative cause for dementia other than Alzheimer's disease as determined by a
required CT or MRI scan within 18 months prior to screening

- 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 as determined thyroid function testing at
screening

- Participant has scheduled or expected hospitalization and/or surgery during the
course of the study

Gender: Both
Steward Physician(s)
  • Samuel T Henderson, PhD
Trial Interventions
Drug
  • AC-1204
  • Placebo
Physician Researcher

Investigator Name:

  • Samuel T Henderson, PhD

Other Information

Sponsor: Accera, Inc.
Phase: Phase 2/Phase 3
Trial ID: NCT01741194
Volunteers:  Not Accepting Healthy Volunteers

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