Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT01001637 |
Recruitment Status : Unknown
Verified October 2009 by Jaslok Hospital and Research Centre.
Recruitment status was: Recruiting
First Posted : October 26, 2009
Last Update Posted : October 26, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Dietary Supplement: Curcumin Formulation Dietary Supplement: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Curcumin Formulation (Longvida) or Placebo on Plasma Biomarkers and Mental State in Moderate to Severe Alzheimer's Disease or Normal Cognition |
Study Start Date : | October 2009 |
Estimated Primary Completion Date : | June 2010 |
Estimated Study Completion Date : | November 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: curcumin |
Dietary Supplement: Curcumin Formulation
2000mg or 3000mg daily BID
Other Name: Longvida |
Placebo Comparator: Placebo |
Dietary Supplement: Placebo
Placebo |
- To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams [ Time Frame: 60 days ]
- To determine if curcumin formulation changes blood concentrations of amyloid-beta [ Time Frame: 60 days ]

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Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or Female age ≥ 50.
- Diagnosed with probable AD using NINDS-ADRDA research criteria. MMSE score ≥5 and ≤20.
- No history of significant psychiatric or non-AD neurological disease.
- An available caregiver to monitor and administer medication and to accompany the subject to every clinical visit.
- On stable doses of concomitant medications for at least one month prior to starting study medication.
Exclusion Criteria:
- Current or recent major psychiatric illness that meets DSM-IV criteria (i.e. bipolar disorder, schizophrenia).
- Significant uncontrolled systemic illness (i.e. chronic renal failure, chronic liver disease, poorly controlled diabetes, or poorly controlled congestive heart failure).
- Recent history of gastrointestinal bleeding or ulceration.
- Alcoholism or substance abuse within the past year per DSM-IV criteria.
- Familial, autosomal dominant Alzheimer's disease due to a mutation in a known gene (Presenilin-1, Presenilin-2, or Amyloid Precursor Protein).

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): NCT01001637
Contact: Fali Poncha, MD | 9820711140 | fali@rediffmail.com | |
Contact: Nitin Kochar, MD | 9819702151 | nitinkochar@gmail.com |
India | |
Jaslok Hospital and research centre | Recruiting |
Mumbai, Maharashtra, India, 400026 | |
Contact: Fali Poncha, MD, DM Neuro 9820711140 fali@rediffmail.com | |
Contact: Nitin Kochar, MD 9819702151 nitinkochar@gmail.com | |
Principal Investigator: Fali Poncha, DM neuro |
Study Director: | Fali Poncha, DM neuro | Jaslok Hospital and Research Centre |
Responsible Party: | Dr Fali Poncha, Jaslok Hospital and Research centre |
ClinicalTrials.gov Identifier: | NCT01001637 |
Other Study ID Numbers: |
Longvida 919820711140 |
First Posted: | October 26, 2009 Key Record Dates |
Last Update Posted: | October 26, 2009 |
Last Verified: | October 2009 |
curcumin alzheimer's longVida dementia |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Curcumin Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |