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| Sponsor: | NeuroBioPharm Inc. |
|---|---|
| Collaborator: |
Neptune Technologies and Bioressources Inc. |
| Information provided by (Responsible Party): | NeuroBioPharm Inc. |
| ClinicalTrials.gov Identifier: | NCT00867828 |
Purpose
The purpose of this study is to evaluate the efficacy of NKO™ softgels in reducing decline of global cognitive function as measured by the Neuropsychological Test Battery (NTB), in patients diagnosed with early stage Alzheimer's disease when compared to fish oil and a placebo after 24 weeks of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Early Onset Alzheimer Disease |
Dietary Supplement: Neptune Krill Oil Dietary Supplement: Fish Oil Dietary Supplement: Placebo (soy oil) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Multi-Center, Double-Blind, Placebo-Controlled, Monotherapy Study of Neptune Krill Oil (NKO™) in Early Stage Alzheimer's Disease |
| Enrollment: | 175 |
| Study Start Date: | May 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Neptune Krill Oil(TM)softgels (1g QD). Each softgel of Neptune Krill Oil will provide approximately 150 mg EPA and 100 mg DHA.
|
Dietary Supplement: Neptune Krill Oil
Softgels 1g QD. Each softgel of Neptune Krill Oil will provide approximately 150 mg EPA and 100 mg DHA.
|
|
Active Comparator: 2
Fish oil softgels (1g QD). Each softgel of Fish Oil will provide approximately 150 mg EPA and 100 mg DHA.
|
Dietary Supplement: Fish Oil
Softgels 1g QD. Each softgel of Fish Oil will provide approximately 150 mg EPA and 100 mg DHA.
|
|
Placebo Comparator: 3
Placebo (soy oil) softgels (1g QD. The soy oil placebo will provide neither EPA nor DHA.
|
Dietary Supplement: Placebo (soy oil)
Softgels 1g QD. The soy oil placebo will provide neither EPA nor DHA.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contacts and Locations| Canada, British Columbia | |
| Surrey, British Columbia, Canada | |
| Canada, Newfoundland and Labrador | |
| Deer Lake, Newfoundland and Labrador, Canada | |
| St. John's, Newfoundland and Labrador, Canada | |
| Canada, Ontario | |
| Cornwall, Ontario, Canada | |
| Hamilton, Ontario, Canada | |
| Hawkesbury, Ontario, Canada | |
| Newmarket, Ontario, Canada | |
| Ottawa, Ontario, Canada | |
| Sarnia, Ontario, Canada | |
| Thornhill, Ontario, Canada | |
| Thunder Bay, Ontario, Canada | |
| Canada, Quebec | |
| Dollard Des Ormeaux, Quebec, Canada | |
| Grand-Mere, Quebec, Canada | |
| Montreal, Quebec, Canada | |
More Information
| Responsible Party: | NeuroBioPharm Inc. |
| ClinicalTrials.gov Identifier: | NCT00867828 History of Changes |
| Obsolete Identifiers: | NCT00861289 |
| Other Study ID Numbers: | NBP-4209AD |
| Study First Received: | March 23, 2009 |
| Last Updated: | September 30, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
|
Decline of global cognitive function Neuropsychological Test Battery (NTB) Early stage Alzheimer's disease |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |