Neptune Krill Oil (NKO™) in Early Stage Alzheimer's Disease (MNEMOSYNE) (MNEMOSYNE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00867828|
Recruitment Status : Completed
First Posted : March 24, 2009
Last Update Posted : October 3, 2011
|Condition or disease||Intervention/treatment||Phase|
|Early Onset Alzheimer Disease||Dietary Supplement: Neptune Krill Oil Dietary Supplement: Fish Oil Dietary Supplement: Placebo (soy oil)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Multi-Center, Double-Blind, Placebo-Controlled, Monotherapy Study of Neptune Krill Oil (NKO™) in Early Stage Alzheimer's Disease|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||January 2011|
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.
- The primary outcome measure will be the change in Neurological Test Battery between baseline and 24 weeks of treatment. [ Time Frame: Between baseline and 24 weeks of treatment ]
- Secondary outcome measures will include the change in DAD at 24 weeks of treatment, the change in NTB, GDS, DAD, and MMSE at 12 weeks.Safety and tolerability will be assessed by the incidence of treatment emergent adverse events. [ Time Frame: 24 week period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867828
|Canada, British Columbia|
|Surrey, British Columbia, Canada|
|Canada, Newfoundland and Labrador|
|Deer Lake, Newfoundland and Labrador, Canada|
|St. John's, Newfoundland and Labrador, Canada|
|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|
|Dollard Des Ormeaux, Quebec, Canada|
|Grand-Mere, Quebec, Canada|
|Montreal, Quebec, Canada|