Disease-modifying Properties of Lithium in the Neurobiology of Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT01055392 |
Recruitment Status : Unknown
Verified December 2009 by University of Sao Paulo.
Recruitment status was: Active, not recruiting
First Posted : January 25, 2010
Last Update Posted : January 25, 2010
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Condition or disease | Intervention/treatment | Phase |
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Cognitive Impairment Alzheimer Disease | Drug: Lithium Carbonate Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Disease-modifying Properties of Lithium in the Neurobiology of Alzheimer's Disease: a Double-blind, Placebo-controlled Prevention Study in Elderly Patients With Mild Cognitive Impairment |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | March 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Lithium
Patients received low doses of lithium salts (from 150 mg to 450 mg of lithium salts daily) to achieve sub-therapeutic lithium levels (target serum lithium level of 0,25 - 0,5 mEq/L). Lithium doses were administered twice a day. Lithium doses were titrated to achieve the target serum lithium levels within the first two weeks after study recruitment. After achieving the target serum lithium level, lithium salts doses remained stable until the end of the study.
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Drug: Lithium Carbonate
lithium carbonate tablets, 150 mg to 450 mg (target serum lithium level 0.25 mEq/L - 0.5 mEq/L), divided in two doses, two years. |
Placebo Comparator: Placebo
Identical placebo tablets were administered twice-a-day for two years.
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Drug: Placebo
Identical placebo tablets were administered twice-a-day for two years. |
- effect of lithium to delay progression of cognitive deficits in patients with amnestic MCI [ Time Frame: two year ]
- effect of lithium on CSF levels of Total Tau, Phosphorylated Tau and Amyloid-beta42 [ Time Frame: one year ]
- the effect of lithium on the activity of GSK3β in platelets and leukocytes drawn from peripheral blood. [ Time Frame: one year ]

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Ages Eligible for Study: | 60 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients with amnestic mild cognitive impairment;
- age: 60 to 80 years-old;
Exclusion Criteria:
- sensory deficiencies that might preclude the administration of cognitive tests;
- active major psychiatry disorder;
- unstable clinical conditions such as cardiac insufficiency, uncontrolled diabetes mellitus, renal failure;
- previous use of lithium salts;
- concurrent participation in other clinical trial or intervention studies;

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): NCT01055392
Brazil | |
Institute of Psychiatry, Faculty of Medicine - University of Sao Paulo | |
Sao Paulo, SP, Brazil, 05403-010 |
Principal Investigator: | Orestes V Forlenza, Ph.D. | Department and Institute of Psychiatry, Faculty of Medicine - University of Sao Paulo | |
Study Director: | Wagner F Gattaz, Ph.D. | Department and Institute of Psychiatry, Faculty of Medicine - University of Sao Paulo |
Responsible Party: | Orestes Vicente Forlenza, Department and Institute of psychiatry, Faculty of Medicine - University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT01055392 |
Other Study ID Numbers: |
OVForlenza-Lithium 554535/2005-0 ( Other Grant/Funding Number: Conselho Nacional de Pesquisa Científica ) |
First Posted: | January 25, 2010 Key Record Dates |
Last Update Posted: | January 25, 2010 |
Last Verified: | December 2009 |
mild cognitive impairment Alzheimer's disease Lithium |
disease-modification cognition early Alzheimer's disease |
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |
Cognition Disorders Lithium Carbonate Antidepressive Agents Psychotropic Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |