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History of Changes for Study: NCT01741194
AC-1204 26-Week Long Term Efficacy Response Trial With Optional Open-label Ext (NOURISH AD)
Latest version (submitted July 30, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 30, 2012 None (earliest Version on record)
2 March 8, 2013 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 May 8, 2013 Outcome Measures, Contacts/Locations and Study Status
4 May 14, 2013 Contacts/Locations and Study Status
5 May 20, 2013 Contacts/Locations and Study Status
6 June 3, 2013 Study Status and Contacts/Locations
7 June 17, 2013 Contacts/Locations and Study Status
8 June 24, 2013 Contacts/Locations and Study Status
9 July 2, 2013 Study Status and Contacts/Locations
10 July 8, 2013 Contacts/Locations and Study Status
11 July 16, 2013 Contacts/Locations and Study Status
12 August 1, 2013 Study Status and Contacts/Locations
13 August 26, 2013 Contacts/Locations and Study Status
14 August 27, 2013 References and Study Status
15 September 9, 2013 Contacts/Locations and Study Status
16 September 16, 2013 Study Status and Contacts/Locations
17 September 23, 2013 Contacts/Locations and Study Status
18 October 14, 2013 Contacts/Locations and Study Status
19 October 30, 2013 Contacts/Locations and Study Status
20 December 2, 2013 Study Status, Contacts/Locations and Eligibility
21 December 16, 2013 Contacts/Locations and Study Status
22 January 6, 2014 Study Status and Contacts/Locations
23 January 29, 2014 Contacts/Locations and Study Status
24 February 3, 2014 Study Status and Contacts/Locations
25 February 18, 2014 Contacts/Locations and Study Status
26 May 1, 2014 Contacts/Locations and Study Status
27 July 11, 2014 Study Status
28 October 22, 2014 Contacts/Locations and Study Status
29 November 4, 2014 Study Status and Contacts/Locations
30 November 10, 2014 Contacts/Locations and Study Status
31 January 6, 2015 Contacts/Locations and Study Status
32 March 10, 2015 Study Status and Contacts/Locations
33 March 11, 2015 Contacts/Locations and Study Status
34 May 11, 2015 Contacts/Locations and Study Status
35 June 10, 2015 Contacts/Locations and Study Status
36 June 17, 2015 Study Status and Contacts/Locations
37 September 28, 2015 Contacts/Locations and Study Status
38 October 26, 2015 Study Status and Contacts/Locations
39 November 23, 2015 Contacts/Locations and Study Status
40 March 22, 2016 Contacts/Locations and Study Status
41 April 5, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
42 February 6, 2017 Study Status
43 April 10, 2017 Study Status and Study Identification
44 May 16, 2017 Recruitment Status, Study Status and Contacts/Locations
45 November 4, 2019 Study Status, Contacts/Locations and Study Identification
46 July 30, 2021 Study Status
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Study NCT01741194
Submitted Date:  November 30, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: AC-12-010
Brief Title: AC-1204 26-Week Long Term Efficacy Response Trial With Optional Open-label Ext (NOURISH AD)
Official Title: 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 (AD) With an Optional 26-Week Open Label Extension
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2012
Overall Status: Not yet recruiting
Study Start: January 2013
Primary Completion: July 2014 [Anticipated]
Study Completion: January 2015 [Anticipated]
First Submitted: November 30, 2012
First Submitted that
Met QC Criteria:
November 30, 2012
First Posted: December 4, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 30, 2012
Last Update Posted: December 4, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Cerecin
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Alzheimer's Disease
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 480 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: AC-1204
Powder formulation (40 g) mixed with 4-8 ounces of water, other liquid or soft food as preferred, and shaken or blended until fully mixed. Each dosing unit of AC-1204 contains 20 g of the active ingredient, caprylic triglyceride.
Drug: AC-1204
AC-1204 taken once daily, by mouth
Placebo Comparator: Placebo
Placebo is an isocaloric formulation prepared to be virtually identical to AC-1204 in appearance, odor and taste. Powdered formulation is mixed with 4-8 ounces of water, other liquid or soft food as preferred, and shaken or blended until fully mixed.
Drug: Placebo
Placebo taken once daily, by mouth
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
[ Time Frame: 26 weeks ]

APOE(-) participants
Secondary Outcome Measures:
1. Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
[ Time Frame: 8 and 17 weeks ]

APOE(-) participants
2. Clock Draw Interpretation Scale (CDIS)
[ Time Frame: 8 and 17 weeks ]

APOE(-) participants
3. Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC)
[ Time Frame: 26 weeks ]

APOE(-) participants
4. Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL)
[ Time Frame: 26 weeks ]

APOE(-) participants
5. Quality of Life - Alzheimer's Disease (QoL-AD)
[ Time Frame: 26 weeks ]

APOE(-) participants
6. Resource Utilization in Dementia (RUD-Lite)
[ Time Frame: 26 weeks ]

APOE(-) participants
7. Mini Mental State Exam (MMSE)
[ Time Frame: 26 weeks ]

APOE(-) participants
8. Incidence of treatment-emergent adverse events
[ Time Frame: 26 weeks ]

All participants
Other Outcome Measures:
1. Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
[ Time Frame: 8 and 17 weeks ]

APOE(+) participants
2. Clock Draw Interpretation Scale (CDIS)
[ Time Frame: 8 and 17 weeks ]

APOE(+) participants
3. Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
[ Time Frame: 26 weeks ]

APOE(+) participants
4. Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC)
[ Time Frame: 26 weeks ]

APOE(+) participants
5. Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL)
[ Time Frame: 26 weeks ]

APOE(+) participants
6. Quality of Life - Alzheimer's Disease (QoL- AD)
[ Time Frame: 26 weeks ]

APOE(+) participants
7. Resource Utilization in Dementia (RUD-Lite)
[ Time Frame: 26 weeks ]

APOE(+) participants
8. Clock Draw Interpretation Scale (CDIS)
[ Time Frame: 26 weeks ]

APOE(+) participants
9. Mini Mental State Exam (MMSE)
[ Time Frame: 26 weeks ]

APOE(+) participants
10. Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
[ Time Frame: 52 weeks ]

All participants
11. Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC)
[ Time Frame: 52 weeks ]

All participants
12. Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL)
[ Time Frame: 52 weeks ]

All participants
13. Quality of Life - Alzheimer's Disease (QoL - AD)
[ Time Frame: 52 weeks ]

All participants
14. Resource Utilization in Dementia (RUD-Lite)
[ Time Frame: 52 weeks ]

All participants
15. Clock Draw Interpretation Scale (CDIS)
[ Time Frame: 52 weeks ]

All participants
16. Ketone body levels (BHB)
[ Time Frame: baseline, 8, 17 and 26 weeks ]

All participants
Open or close this module Eligibility
Minimum Age: 66 Years
Maximum Age: 90 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Janet Vogel
Telephone: 303.999-3703
Email: jvogel@accerapharma.com
Central Contact Backup: Sabrina Greer
Telephone: 303.999.3743
Email: sgreer@accerapharma.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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