NOURISH-AD: AC-1204 26-Week Long Term Efficacy Response Trial With Optional Open-label Ext

Sponsor

Cerecin (Industry)

Overall Status

Completed

CT.gov ID

NCT01741194

Collaborator

(none)

418

Enrollment

Locations

Arms

49.4

Duration (Months)

5.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: AC-1204 Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

418 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Oct 24, 2016

Actual Study Completion Date :

Apr 14, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [26 weeks]
APOE(-) participants

Secondary Outcome Measures

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [8 and 17 weeks]
APOE(-) participants
Clock Draw Interpretation Scale (CDIS) [8 and 17 weeks]
APOE(-) participants
Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [26 weeks]
APOE(-) participants
Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [26 weeks]
APOE(-) participants
Quality of Life - Alzheimer's Disease (QoL-AD) [26 weeks]
APOE(-) participants
Resource Utilization in Dementia (RUD-Lite) [26 weeks]
APOE(-) participants
Incidence of treatment-emergent adverse events [26 weeks]
All participants

Other Outcome Measures

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [26 weeks]
APOE(+) participants
Clock Draw Interpretation Scale (CDIS) [26 weeks]
APOE(+) participants
Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [26 weeks]
APOE(+) participants
Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [26 weeks]
APOE(+) participants
Quality of Life - Alzheimer's Disease (QoL- AD) [26 weeks]
APOE(+) participants
Resource Utilization in Dementia (RUD-Lite) [26 weeks]
APOE(+) participants
Mini Mental State Exam (MMSE) [26 weeks]
APOE(+) participants
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [52 weeks]
All participants
Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [52 weeks]
All participants
Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [52 weeks]
All participants
Quality of Life - Alzheimer's Disease (QoL - AD) [52 weeks]
All participants
Resource Utilization in Dementia (RUD-Lite) [52 weeks]
All participants
Clock Draw Interpretation Scale (CDIS) [52 weeks]
All participants
Ketone body levels (BHB) [baseline, 8, 17 and 26 weeks]
All participants
Incidence of treatment-emergent adverse events [52 weeks]
All participants
Mini Mental State Exam (MMSE) [52 weeks]
All participants

Eligibility Criteria

Criteria

Ages Eligible for Study:

66 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 60 days 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
Inflammatory bowel disease or peptic ulcer disease.
Participants with current or a history of (within the last 5 years) complicated reflux disease or severe GERD that is not well-controlled by medication.
Irritable bowel syndrome, diverticular disease (e.g., diverticulosis or diverticulitis), or chronic gastritis (exclusionary if there has been a diagnosis or an acute event within 5 years prior to Screening.)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham, Department of Neurology, Memory Disorders Division	Birmingham	Alabama	United States	35294
2	Banner Alzheimer's Institute	Phoenix	Arizona	United States	85006
3	HOPE Research Institute	Phoenix	Arizona	United States	85018
4	Principals Research Group	Hot Springs	Arkansas	United States	71901
5	Clinical Trials, Inc.	Little Rock	Arkansas	United States	72205
6	CITrials, Inc.	Bellflower	California	United States	90706
7	Southern Research LLC	Beverly Hills	California	United States	90210
8	ATP Clinical Research, Inc.	Costa Mesa	California	United States	92626
9	Diligent Clinical Trials	Downey	California	United States	90241
10	UCSD Comprehensive Alzheimer's Program	La Jolla	California	United States	92037
11	Alliance Research Centers	Laguna Hills	California	United States	92653
12	Senior Clinical Trials, Inc.	Laguna Hills	California	United States	92653
13	Collaborative Neuroscience Network	Long Beach	California	United States	90806
14	Alliance for Research	Long Beach	California	United States	90807
15	Renew Behavioral Health	Long Beach	California	United States	90807
16	Pacific Research Network	San Diego	California	United States	92103
17	Artemis Institute for Clinical Research	San Diego	California	United States	92123
18	Research Across America	Santa Ana	California	United States	92705
19	Neurological Research Institute	Santa Monica	California	United States	90404
20	Redwood Research Medical Group	Santa Rosa	California	United States	95403
21	Alpine Clinical Research Center	Boulder	Colorado	United States	80304
22	IMMUNOe Research Centers	Centennial	Colorado	United States	80112
23	The Mile High Research Center	Denver	Colorado	United States	80218
24	Chase Medical Research of Greater New Haven	Hamden	Connecticut	United States	06517
25	Chase Medical Research, LLC	Waterbury	Connecticut	United States	06708
26	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida	United States	33486
27	Meridian Research	Brooksville	Florida	United States	34601
28	Brain Matters Research	Delray Beach	Florida	United States	33445
29	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida	United States	33912
30	MD Clinical	Hallandale Beach	Florida	United States	33009
31	Alzheimer's Research and Treatment Center	Lake Worth	Florida	United States	33449
32	Miami Jewish Health Systems	Miami	Florida	United States	33137
33	Compass Research, LLC	Orlando	Florida	United States	32806
34	Meridien Research	Saint Petersburg	Florida	United States	33709
35	Suncoast Neuroscience Associates	Saint Petersburg	Florida	United States	33713
36	The Roskamp Institute	Sarasota	Florida	United States	34243
37	Axiom Clinical Research of Florida	Tampa	Florida	United States	33609
38	Stedman Clinical Trials	Tampa	Florida	United States	33613
39	Premiere Research Institute	West Palm Beach	Florida	United States	33407
40	NeuroTrials Research, Inc	Atlanta	Georgia	United States	30342
41	IU Health Partners Adult Neurology Clinic	Indianapolis	Indiana	United States	46202
42	Lake Charles Clinical Trials	Lake Charles	Louisiana	United States	70629
43	Pharmasite Research, Inc.	Baltimore	Maryland	United States	21208
44	Alzheimers Disease Center, Quincy Medical Center	Somerville	Massachusetts	United States	02169
45	Springfield Neurology Associates	Springfield	Massachusetts	United States	01104
46	Borgess Research Institute	Kalamazoo	Michigan	United States	49048
47	Saint Louis University Medical School /Department of Neurology & Psychiatry	Saint Louis	Missouri	United States	63104
48	Cleveland Clinic Lou Ruvo Center for Brain Health	Las Vegas	Nevada	United States	89106
49	Comprehensive Clinical Research	Berlin	New Jersey	United States	08009
50	Alzheimer's Research Corporation	Manchester	New Jersey	United States	08759
51	NeuroCognitive Institute	Mount Arlington	New Jersey	United States	07856
52	The Cognitive Research Center of New Jersey	Springfield	New Jersey	United States	07081
53	Memory Enhancement Center of NJ	Toms River	New Jersey	United States	08755
54	Neurology Specialists of Monmouth County	West Long Branch	New Jersey	United States	07764
55	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico	United States	87109
56	Integrative Clinical Trials, LLC	Brooklyn	New York	United States	11229
57	SPRI Clinical Trials, LLC	Brooklyn	New York	United States	11235
58	The Litwin-Zucker Research Center	Manhasset	New York	United States	11030
59	Parker Jewish Institute For Health Care & Rehabilitation	New Hyde Park	New York	United States	11040
60	NYU Langone Medical Center Comprehensive Center on Brain Aging	New York	New York	United States	10016
61	Eastside Comprehensive Medical Center, LLC	New York	New York	United States	10021
62	Nathan S. Kline Institute Geriatric Psychiatry Program	Orangeburg	New York	United States	10962
63	New Hope Clinical Research	Charlotte	North Carolina	United States	28204
64	Ani Neurology, PLLC dba Alzheimer's Memory Ctr	Charlotte	North Carolina	United States	28211
65	Neuro-Behavioral Clinical Research, Inc.	Canton	Ohio	United States	44718
66	Valley Medical Research	Centerville	Ohio	United States	45459
67	CTI Clinical Research Center	Cincinnati	Ohio	United States	45227
68	Insight Clinical Trials LLC	Shaker Heights	Ohio	United States	44122
69	IPS Research Company	Oklahoma City	Oklahoma	United States	73103
70	Summit Research Network (Oregon) Inc.	Portland	Oregon	United States	97210
71	Drexel Neurological Associates	Philadelphia	Pennsylvania	United States	19107
72	Abington Neurological Associates	Willow Grove	Pennsylvania	United States	19090
73	Medical University of South Carolina	Charleston	South Carolina	United States	29406
74	Neurology Clinic, P.C.	Cordova	Tennessee	United States	38018
75	Clinical Research Solutions	Franklin	Tennessee	United States	37064
76	Clinical Neuroscience Solutions, Inc	Memphis	Tennessee	United States	38119
77	Senior Adults Specialty Research, Inc	Austin	Texas	United States	78757
78	Texas Neurology	Dallas	Texas	United States	75214
79	Baylor College of Medicine	Houston	Texas	United States	77030
80	Wasatch Clinical Research	Salt Lake City	Utah	United States	84107
81	National Clinical Research - Richmond, Inc.	Richmond	Virginia	United States	23294
82	VA Puget Sound-Alzhemier's Disease Research Center	Seattle	Washington	United States	98108

Sponsors and Collaborators

Cerecin

Investigators

Study Director: Samuel T Henderson, PhD, Cerecin

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Alzheimer's Survey

Publications

None provided.

Responsible Party:

Cerecin

ClinicalTrials.gov Identifier:

NCT01741194

Other Study ID Numbers:

AC-12-010

First Posted:

Dec 4, 2012

Last Update Posted:

Aug 2, 2021

Last Verified:

Jul 1, 2021

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Aug 2, 2021