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

Alzheimer's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741194
• Other study ID #: AC-12-010
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2013
• Est. completion date: April 14, 2017

Study information

• Verified date: July 2021
• Source: Cerecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: April 14, 2017
• Est. primary completion date: October 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Years to 90 Years

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 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• AC-1204
AC-1204 taken once daily, by mouth
• Placebo
Placebo taken once daily, by mouth

Locations

Country	Name	City	State
United States	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
United States	NeuroTrials Research, Inc	Atlanta	Georgia
United States	Senior Adults Specialty Research, Inc	Austin	Texas
United States	Pharmasite Research, Inc.	Baltimore	Maryland
United States	CITrials, Inc.	Bellflower	California
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Southern Research LLC	Beverly Hills	California
United States	University of Alabama at Birmingham, Department of Neurology, Memory Disorders Division	Birmingham	Alabama
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Integrative Clinical Trials, LLC	Brooklyn	New York
United States	SPRI Clinical Trials, LLC	Brooklyn	New York
United States	Meridian Research	Brooksville	Florida
United States	Neuro-Behavioral Clinical Research, Inc.	Canton	Ohio
United States	IMMUNOe Research Centers	Centennial	Colorado
United States	Valley Medical Research	Centerville	Ohio
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Ani Neurology, PLLC dba Alzheimer's Memory Ctr	Charlotte	North Carolina
United States	New Hope Clinical Research	Charlotte	North Carolina
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Neurology Clinic, P.C.	Cordova	Tennessee
United States	ATP Clinical Research, Inc.	Costa Mesa	California
United States	Texas Neurology	Dallas	Texas
United States	Brain Matters Research	Delray Beach	Florida
United States	The Mile High Research Center	Denver	Colorado
United States	Diligent Clinical Trials	Downey	California
United States	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida
United States	Clinical Research Solutions	Franklin	Tennessee
United States	MD Clinical	Hallandale Beach	Florida
United States	Chase Medical Research of Greater New Haven	Hamden	Connecticut
United States	Principals Research Group	Hot Springs	Arkansas
United States	Baylor College of Medicine	Houston	Texas
United States	IU Health Partners Adult Neurology Clinic	Indianapolis	Indiana
United States	Borgess Research Institute	Kalamazoo	Michigan
United States	UCSD Comprehensive Alzheimer's Program	La Jolla	California
United States	Alliance Research Centers	Laguna Hills	California
United States	Senior Clinical Trials, Inc.	Laguna Hills	California
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Alzheimer's Research and Treatment Center	Lake Worth	Florida
United States	Cleveland Clinic Lou Ruvo Center for Brain Health	Las Vegas	Nevada
United States	Clinical Trials, Inc.	Little Rock	Arkansas
United States	Alliance for Research	Long Beach	California
United States	Collaborative Neuroscience Network	Long Beach	California
United States	Renew Behavioral Health	Long Beach	California
United States	Alzheimer's Research Corporation	Manchester	New Jersey
United States	The Litwin-Zucker Research Center	Manhasset	New York
United States	Clinical Neuroscience Solutions, Inc	Memphis	Tennessee
United States	Miami Jewish Health Systems	Miami	Florida
United States	NeuroCognitive Institute	Mount Arlington	New Jersey
United States	Parker Jewish Institute For Health Care & Rehabilitation	New Hyde Park	New York
United States	Eastside Comprehensive Medical Center, LLC	New York	New York
United States	NYU Langone Medical Center Comprehensive Center on Brain Aging	New York	New York
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Nathan S. Kline Institute Geriatric Psychiatry Program	Orangeburg	New York
United States	Compass Research, LLC	Orlando	Florida
United States	Drexel Neurological Associates	Philadelphia	Pennsylvania
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	HOPE Research Institute	Phoenix	Arizona
United States	Summit Research Network (Oregon) Inc.	Portland	Oregon
United States	National Clinical Research - Richmond, Inc.	Richmond	Virginia
United States	Saint Louis University Medical School /Department of Neurology & Psychiatry	Saint Louis	Missouri
United States	Meridien Research	Saint Petersburg	Florida
United States	Suncoast Neuroscience Associates	Saint Petersburg	Florida
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Pacific Research Network	San Diego	California
United States	Research Across America	Santa Ana	California
United States	Neurological Research Institute	Santa Monica	California
United States	Redwood Research Medical Group	Santa Rosa	California
United States	The Roskamp Institute	Sarasota	Florida
United States	VA Puget Sound-Alzhemier's Disease Research Center	Seattle	Washington
United States	Insight Clinical Trials LLC	Shaker Heights	Ohio
United States	Alzheimers Disease Center, Quincy Medical Center	Somerville	Massachusetts
United States	Springfield Neurology Associates	Springfield	Massachusetts
United States	The Cognitive Research Center of New Jersey	Springfield	New Jersey
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	Stedman Clinical Trials	Tampa	Florida
United States	Memory Enhancement Center of NJ	Toms River	New Jersey
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Neurology Specialists of Monmouth County	West Long Branch	New Jersey
United States	Premiere Research Institute	West Palm Beach	Florida
United States	Abington Neurological Associates	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cerecin

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Alzheimer's Survey